NCT03576131 is a Phase 1, PHASE2 clinical trial of GEN1029 (HexaBody®-DR5/DR5) in Colorectal Cancer, sponsored by Genmab.

Who is sponsoring NCT03576131?

NCT03576131 is sponsored by Genmab.

What drugs are being tested in NCT03576131?

Interventions in NCT03576131: GEN1029 (HexaBody®-DR5/DR5).

What condition does NCT03576131 study?

NCT03576131 studies Colorectal Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Renal Cell Carcinoma, Gastric Cancer, Pancreatic Cancer, Urothelial Cancer.

Is NCT03576131 still recruiting?

NCT03576131 is currently terminated. Last updated 1 August 2023.

Are results published for NCT03576131?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-08-01 · How we verify

NCT03576131

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors

Terminated Phase 1, PHASE2 Results posted Last updated 1 August 2023

What this trial tests

Phase 1, PHASE2 trial testing GEN1029 (HexaBody®-DR5/DR5) in Colorectal Cancer in 48 participants. Terminated before completion.

Timeline

30 April 2018

Primary endpoint
12 October 2021

12 October 2021

Quick facts

Lead sponsor	Genmab
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	30 April 2018
Primary completion	12 October 2021
Estimated completion	12 October 2021
Sites	6 locations across United Kingdom, United States, Spain

Drugs / interventions tested

GEN1029 (HexaBody®-DR5/DR5) — full drug profile →

Conditions studied

Colorectal Cancer — all drugs for Colorectal Cancer →
Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →
Renal Cell Carcinoma — all drugs for Renal Cell Carcinoma →

Sponsor

Genmab — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer or Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Dose Limiting Toxicities (DLTs) Primary · From Day 1 to 28 days after the first dose of study drug

DLT criteria in the dose escalation phase of this trial are defined as hematologic toxicity including Grade (G) 4 neutropenia/thrombocytopenia for minimal duration of 7 days, G3/4 febrile neutropenia, \>=G3 thrombocytopenia with bleeding, or G4 anemia; and non-hematologic toxicity including G4 infusion-related reactions (IRR) or anaphylaxis, G3 IRR did not resolve to =\<G1 within 24 hours, \>=G3 diarrhea/vomiting (did not respond to optimal treatment within 2 days), G3 nausea (did not respond to optimal treatment within 7days), or Hy's law or protocol-specified toxicities related to liver func

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	1
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	3
Biweekly Regimen (GEN1029 2.0 mg/kg)	3
Biweekly Regimen (GEN1029 3.0 mg/kg)	2

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) Primary · Day 1 through Day 565 (corresponding to maximum observed duration)

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is defined as an AE that meets one of the following criteria: fatal or life-threatening; results in persistent or significant disability/incapacity; constitutes a congenital anomaly/birth defect; medically significant (an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above \[medical and scientific judgment must be exercised in deciding whether an AE is 'medica

Any TEAE

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	8
Biweekly Regimen (GEN1029 0.2 mg/kg)	7
Biweekly Regimen (GEN1029 0.3 mg/kg)	4
Biweekly Regimen (GEN1029 1.0 mg/kg)	11
Biweekly Regimen (GEN1029 2.0 mg/kg)	7
Biweekly Regimen (GEN1029 3.0 mg/kg)	7

Any TESAE

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	3
Biweekly Regimen (GEN1029 0.2 mg/kg)	3
Biweekly Regimen (GEN1029 0.3 mg/kg)	2
Biweekly Regimen (GEN1029 1.0 mg/kg)	9
Biweekly Regimen (GEN1029 2.0 mg/kg)	6
Biweekly Regimen (GEN1029 3.0 mg/kg)	4

Number of Participants With >= Grade 3 Laboratory Results Primary · Day 1 through Day 565 (corresponding to maximum observed duration)

Number of participants with laboratory measurements of Grade \>= 3 by NCI-CTCAE v4.03 are reported. The NCI-CTCAE is a descriptive terminology is used for AE reporting. The NCI-CTCAE v4.03 displays Grades 1 through 5 with unique clinical descriptions of severity for each AE. Based on this general guideline: Grade 1 as mild AE, Grade 2 as moderate AE, Grade 3 as severe AE, Grade 4 as life-threatening or disabling AE, and Grade 5 as death. In case a participant reported multiple severity grades for an AE, only the maximum grade was used.

Activated partial thromboplastin time prolonged

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	1
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Alanine aminotransferase increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	1
Biweekly Regimen (GEN1029 0.2 mg/kg)	1
Biweekly Regimen (GEN1029 0.3 mg/kg)	2
Biweekly Regimen (GEN1029 1.0 mg/kg)	3
Biweekly Regimen (GEN1029 2.0 mg/kg)	1
Biweekly Regimen (GEN1029 3.0 mg/kg)	2

Alkaline phosphatase increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	0
Biweekly Regimen (GEN1029 0.3 mg/kg)	1
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	1
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Amylase increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	1
Biweekly Regimen (GEN1029 0.3 mg/kg)	1
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Asparate aminotransferase increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	1
Biweekly Regimen (GEN1029 0.2 mg/kg)	2
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	2

Bilirubin increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	1
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Calcium decreased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0
Biweekly Regimen (GEN1029 0.2 mg/kg)	1
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Creatinine increased

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	1
Biweekly Regimen (GEN1029 0.2 mg/kg)	0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Maximum Observed Plasma Concentration (Cmax) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The Cmax of Hx-DR5-01 and Hx-DR5-05 are reported.

Cmax Hx-DR5-01 Cycle 1 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.86	± 36.8
Biweekly Regimen (GEN1029 0.2 mg/kg)	1.90	± 38.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	2.81	± 28.9
Biweekly Regimen (GEN1029 1.0 mg/kg)	9.79	± 20.9
Biweekly Regimen (GEN1029 2.0 mg/kg)	21.31	± 24.6
Biweekly Regimen (GEN1029 3.0 mg/kg)	29.75	± 24.9

Cmax Hx-DR5-01 Cycle 2 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.79	± 42.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	2.11	± 18.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	1.12	± 59.9
Biweekly Regimen (GEN1029 1.0 mg/kg)	8.36	± 22.7
Biweekly Regimen (GEN1029 2.0 mg/kg)	13.13	± 156.3
Biweekly Regimen (GEN1029 3.0 mg/kg)	29.56	± 7.7

Cmax Hx-DR5-01 Cycle 3 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.89	± 16.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	1.82	± 53.9
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.89	± 146.4
Biweekly Regimen (GEN1029 1.0 mg/kg)	7.20	± 11.2
Biweekly Regimen (GEN1029 2.0 mg/kg)	20.35	± 24.7
Biweekly Regimen (GEN1029 3.0 mg/kg)	28.80	± NA

Cmax Hx-DR5-05 Cycle 1 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.87	± 45.2
Biweekly Regimen (GEN1029 0.2 mg/kg)	1.81	± 35.7
Biweekly Regimen (GEN1029 0.3 mg/kg)	2.82	± 31.8
Biweekly Regimen (GEN1029 1.0 mg/kg)	9.72	± 17.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	20.90	± 21.9
Biweekly Regimen (GEN1029 3.0 mg/kg)	29.44	± 27.9

Cmax Hx-DR5-05 Cycle 2 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.79	± 25.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	2.00	± 18.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	1.11	± 76.2
Biweekly Regimen (GEN1029 1.0 mg/kg)	7.75	± 25.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	20.37	± 14.3
Biweekly Regimen (GEN1029 3.0 mg/kg)	30.52	± 5.8

Cmax Hx-DR5-05 Cycle 3 (Day 1)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.87	± 26.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	1.28	± 93.8
Biweekly Regimen (GEN1029 0.3 mg/kg)	1.62	± 108.2
Biweekly Regimen (GEN1029 1.0 mg/kg)	6.77	± 20.6
Biweekly Regimen (GEN1029 2.0 mg/kg)	5.27	± 577.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	28.50	± NA

Area Under Plasma Concentration-time Curve From Time Zero to Infinity (AUC[0-inf]) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The AUC(0-inf) of Hx-DR5-01 and Hx-DR5-05 are reported.

AUC(0-inf) Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	39.44	± 50.2
Biweekly Regimen (GEN1029 0.2 mg/kg)	91.20	± 66.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	85.80	± 56.7
Biweekly Regimen (GEN1029 1.0 mg/kg)	523.66	± 47.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	1298.0	± 22.7
Biweekly Regimen (GEN1029 3.0 mg/kg)	1497.7	± 58.7

AUC(0-inf) Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	46.37	± 61.5
Biweekly Regimen (GEN1029 0.2 mg/kg)	105.32	± 55.8
Biweekly Regimen (GEN1029 0.3 mg/kg)	35.24	± 30.5
Biweekly Regimen (GEN1029 1.0 mg/kg)	530.48	± 24.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	1071.5	± 30.7
Biweekly Regimen (GEN1029 3.0 mg/kg)	2488.5	± 10.7

AUC(0-inf) Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	37.43	± 74.0
Biweekly Regimen (GEN1029 0.2 mg/kg)	53.24	± 133.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	41.41	± 84.9
Biweekly Regimen (GEN1029 1.0 mg/kg)	422.32	± 26.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	1097.8	± 36.6
Biweekly Regimen (GEN1029 3.0 mg/kg)	2653.5	± NA

AUC(0-inf) Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	32.97	± 55.4
Biweekly Regimen (GEN1029 0.2 mg/kg)	71.21	± 66.9
Biweekly Regimen (GEN1029 0.3 mg/kg)	83.37	± 51.7
Biweekly Regimen (GEN1029 1.0 mg/kg)	508.76	± 33.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	1052.1	± 24.7
Biweekly Regimen (GEN1029 3.0 mg/kg)	1270.0	± 60.1

AUC(0-inf) Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	39.31	± 65.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	93.11	± 66.6
Biweekly Regimen (GEN1029 0.3 mg/kg)	44.76	± 184.4
Biweekly Regimen (GEN1029 1.0 mg/kg)	414.90	± 24.1
Biweekly Regimen (GEN1029 2.0 mg/kg)	609.90	± 55.2
Biweekly Regimen (GEN1029 3.0 mg/kg)	2273.6	± 9.0

AUC(0-inf) Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	25.87	± 57.3
Biweekly Regimen (GEN1029 0.2 mg/kg)	51.36	± 161.6
Biweekly Regimen (GEN1029 0.3 mg/kg)	67.23	± 200.5
Biweekly Regimen (GEN1029 1.0 mg/kg)	231.49	± 53.2
Biweekly Regimen (GEN1029 2.0 mg/kg)	412.87	± 64.1
Biweekly Regimen (GEN1029 3.0 mg/kg)	2398.5	± NA

Area Under Plasma Concentration-time Curve From Time Zero to the Time of Last Nonzero Concentration (AUC[0-Clast]) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The AUC(0-Clast) of Hx-DR5-01 and Hx-DR5-05 are reported.

AUC(0-Clast) Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	24.36	± 73.2
Biweekly Regimen (GEN1029 0.2 mg/kg)	72.25	± 70.6
Biweekly Regimen (GEN1029 0.3 mg/kg)	60.78	± 35.8
Biweekly Regimen (GEN1029 1.0 mg/kg)	460.37	± 43.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	1173.7	± 15.6
Biweekly Regimen (GEN1029 3.0 mg/kg)	1058.9	± 88.6

AUC(0-Clast) Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	17.34	± 141.3
Biweekly Regimen (GEN1029 0.2 mg/kg)	70.33	± 66.4
Biweekly Regimen (GEN1029 0.3 mg/kg)	21.85	± 36.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	308.74	± 66.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	582.57	± 84.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	2291.4	± 18.1

AUC(0-Clast) Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	22.34	± 85.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	35.31	± 151.4
Biweekly Regimen (GEN1029 0.3 mg/kg)	6.85	± 995.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	385.54	± 23.7
Biweekly Regimen (GEN1029 2.0 mg/kg)	986.38	± 30.1
Biweekly Regimen (GEN1029 3.0 mg/kg)	2444.7	± NA

AUC(0-Clast) Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	25.41	± 120.7
Biweekly Regimen (GEN1029 0.2 mg/kg)	53.76	± 77.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	53.80	± 50.8
Biweekly Regimen (GEN1029 1.0 mg/kg)	432.18	± 24.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	956.02	± 18.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	964.48	± 91.1

AUC(0-Clast) Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	24.85	± 119.4
Biweekly Regimen (GEN1029 0.2 mg/kg)	60.75	± 76.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	29.17	± 165.1
Biweekly Regimen (GEN1029 1.0 mg/kg)	258.67	± 60.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	395.50	± 62.3
Biweekly Regimen (GEN1029 3.0 mg/kg)	2176.0	± 11.7

AUC(0-Clast) Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	20.12	± 168.7
Biweekly Regimen (GEN1029 0.2 mg/kg)	16.95	± 539.4
Biweekly Regimen (GEN1029 0.3 mg/kg)	43.56	± 405.4
Biweekly Regimen (GEN1029 1.0 mg/kg)	158.98	± 76.4
Biweekly Regimen (GEN1029 2.0 mg/kg)	52.16	± 22162.5
Biweekly Regimen (GEN1029 3.0 mg/kg)	2248.1	± NA

Total Clearance (CL) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The CL of Hx-DR5-01 and Hx-DR5-05 are reported.

CL Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	95.98	± 53.8
Biweekly Regimen (GEN1029 0.2 mg/kg)	91.27	± 51.4
Biweekly Regimen (GEN1029 0.3 mg/kg)	123.75	± 69.9
Biweekly Regimen (GEN1029 1.0 mg/kg)	65.36	± 56.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	59.07	± 31.4
Biweekly Regimen (GEN1029 3.0 mg/kg)	69.50	± 51.0

CL Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	77.36	± 70.2
Biweekly Regimen (GEN1029 0.2 mg/kg)	79.97	± 51.8
Biweekly Regimen (GEN1029 0.3 mg/kg)	155.76	± 72.6
Biweekly Regimen (GEN1029 1.0 mg/kg)	58.07	± 31.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	73.43	± 28.0
Biweekly Regimen (GEN1029 3.0 mg/kg)	36.92	± 2.0

CL Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	99.53	± 57.1
Biweekly Regimen (GEN1029 0.2 mg/kg)	131.46	± 76.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	111.33	± 12.9
Biweekly Regimen (GEN1029 1.0 mg/kg)	62.90	± 42.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	62.64	± 26.1
Biweekly Regimen (GEN1029 3.0 mg/kg)	37.87	± NA

CL Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	111.10	± 62.5
Biweekly Regimen (GEN1029 0.2 mg/kg)	116.89	± 51.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	127.35	± 69.3
Biweekly Regimen (GEN1029 1.0 mg/kg)	67.28	± 37.4
Biweekly Regimen (GEN1029 2.0 mg/kg)	69.39	± 29.2
Biweekly Regimen (GEN1029 3.0 mg/kg)	81.96	± 53.9

CL Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	90.18	± 69.4
Biweekly Regimen (GEN1029 0.2 mg/kg)	90.45	± 67.1
Biweekly Regimen (GEN1029 0.3 mg/kg)	131.51	± 240.7
Biweekly Regimen (GEN1029 1.0 mg/kg)	79.72	± 28.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	134.11	± 51.9
Biweekly Regimen (GEN1029 3.0 mg/kg)	40.41	± 3.7

CL Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	143.09	± 50.5
Biweekly Regimen (GEN1029 0.2 mg/kg)	140.38	± 77.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	68.57	± 42.2
Biweekly Regimen (GEN1029 1.0 mg/kg)	114.74	± 59.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	172.66	± 78.9
Biweekly Regimen (GEN1029 3.0 mg/kg)	41.90	± NA

Volume of Distribution (Vss) at Steady State of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The Vss of Hx-DR5-01 and Hx-DR5-05 are reported.

Vss Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	5366.8	± 35.0
Biweekly Regimen (GEN1029 0.2 mg/kg)	4788.6	± 5.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	3666.8	± 49.4
Biweekly Regimen (GEN1029 1.0 mg/kg)	3834.6	± 34.3
Biweekly Regimen (GEN1029 2.0 mg/kg)	4885.9	± 18.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	4127.3	± 19.2

Vss Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	4720.0	± 34.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	4287.5	± 10.5
Biweekly Regimen (GEN1029 0.3 mg/kg)	5283.0	± 62.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	3998.1	± 24.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	4185.8	± 17.3
Biweekly Regimen (GEN1029 3.0 mg/kg)	3427.5	± 25.1

Vss Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	4622.7	± 31.1
Biweekly Regimen (GEN1029 0.2 mg/kg)	4531.9	± 6.7
Biweekly Regimen (GEN1029 0.3 mg/kg)	3243.6	± 14.3
Biweekly Regimen (GEN1029 1.0 mg/kg)	4075.3	± 26.2
Biweekly Regimen (GEN1029 2.0 mg/kg)	4227.1	± 8.7
Biweekly Regimen (GEN1029 3.0 mg/kg)	4118.5	± NA

Vss Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	4722.7	± 55.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	5242.9	± 15.8
Biweekly Regimen (GEN1029 0.3 mg/kg)	3942.4	± 63.6
Biweekly Regimen (GEN1029 1.0 mg/kg)	3611.0	± 26.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	4291.6	± 9.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	4142.9	± 21.0

Vss Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	4899.3	± 22.7
Biweekly Regimen (GEN1029 0.2 mg/kg)	4701.6	± 15.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	5177.9	± 100.6
Biweekly Regimen (GEN1029 1.0 mg/kg)	4054.4	± 16.4
Biweekly Regimen (GEN1029 2.0 mg/kg)	4334.9	± 14.9
Biweekly Regimen (GEN1029 3.0 mg/kg)	3187.8	± 41.0

Vss Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	4812.5	± 31.9
Biweekly Regimen (GEN1029 0.2 mg/kg)	5077.6	± 24.1
Biweekly Regimen (GEN1029 0.3 mg/kg)	3577.1	± 15.7
Biweekly Regimen (GEN1029 1.0 mg/kg)	4951.2	± 42.4
Biweekly Regimen (GEN1029 2.0 mg/kg)	5130.8	± 5.6
Biweekly Regimen (GEN1029 3.0 mg/kg)	4173.9	± NA

Half-life Lambda-z (t1/2) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The t1/2 of Hx-DR5-01 and Hx-DR5-05 are reported.

T1/2 Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	41.69	20.7 – 61.1
Biweekly Regimen (GEN1029 0.2 mg/kg)	41.31	16.6 – 60.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	18.10	11.4 – 40.5
Biweekly Regimen (GEN1029 1.0 mg/kg)	40.27	5.1 – 66.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	70.90	50.5 – 86.2
Biweekly Regimen (GEN1029 3.0 mg/kg)	42.45	17.9 – 80.5

T1/2 Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	37.75	29.1 – 72.3
Biweekly Regimen (GEN1029 0.2 mg/kg)	39.57	21.7 – 62.5
Biweekly Regimen (GEN1029 0.3 mg/kg)	24.47	16.9 – 29.7
Biweekly Regimen (GEN1029 1.0 mg/kg)	49.64	36.2 – 71.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	33.62	29.0 – 88.2
Biweekly Regimen (GEN1029 3.0 mg/kg)	65.85	54.6 – 77.1

T1/2 Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	27.64	16.2 – 84.1
Biweekly Regimen (GEN1029 0.2 mg/kg)	19.93	13.1 – 66.9
Biweekly Regimen (GEN1029 0.3 mg/kg)	20.16	16.2 – 24.1
Biweekly Regimen (GEN1029 1.0 mg/kg)	47.86	30.8 – 60.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	44.51	40.1 – 64.0
Biweekly Regimen (GEN1029 3.0 mg/kg)	77.00	77.00 – 77.00

T1/2 Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	35.55	12.5 – 46.5
Biweekly Regimen (GEN1029 0.2 mg/kg)	34.50	15.6 – 52.5
Biweekly Regimen (GEN1029 0.3 mg/kg)	19.10	14.6 – 44.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	36.33	26.4 – 70.6
Biweekly Regimen (GEN1029 2.0 mg/kg)	42.68	35.3 – 68.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	37.71	16.6 – 69.6

T1/2 Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	32.46	19.3 – 71.4
Biweekly Regimen (GEN1029 0.2 mg/kg)	37.71	17.3 – 80.7
Biweekly Regimen (GEN1029 0.3 mg/kg)	25.43	13.9 – 62.3
Biweekly Regimen (GEN1029 1.0 mg/kg)	37.69	28.4 – 43.5
Biweekly Regimen (GEN1029 2.0 mg/kg)	26.68	13.1 – 29.4
Biweekly Regimen (GEN1029 3.0 mg/kg)	51.97	30.8 – 73.1

T1/2 Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	25.30	12.0 – 39.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	18.75	15.4 – 57.4
Biweekly Regimen (GEN1029 0.3 mg/kg)	41.26	24.3 – 58.2
Biweekly Regimen (GEN1029 1.0 mg/kg)	33.90	14.2 – 62.1
Biweekly Regimen (GEN1029 2.0 mg/kg)	22.83	13.2 – 32.5
Biweekly Regimen (GEN1029 3.0 mg/kg)	70.9	70.9 – 70.9

Time to Reach Maximum Observed Concentration (Tmax) of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The Tmax of Hx-DR5-01 and Hx-DR5-05 are reported.

Tmax Hx-DR5-01 Cycle 1 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	1.58	1.1 – 5.8
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	1.89	1.4 – 5.0
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	1.23	1.2 – 1.4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	2.00	0.1 – 4.7
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	1.30	1.1 – 3.6
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	1.46	1.0 – 3.1

Tmax Hx-DR5-01 Cycle 2 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	1.25	1.0 – 3.2
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	3.03	3.0 – 5.2
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	1.30	1.1 – 3.2
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	3.06	1.1 – 5.1
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	3.25	1.1 – 163.7
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	1.11	1.0 – 1.2

Tmax Hx-DR5-01 Cycle 3 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	1.08	0.0 – 3.4
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	1.48	1.0 – 2.1
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	1.13	1.1 – 1.3
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	3.08	1.4 – 3.5
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	1.82	1.1 – 3.2
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	3.1	3.1 – 3.1

Tmax Hx-DR5-05 Cycle 1 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	1.75	1.1 – 5.4
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	2.53	1.0 – 4.8
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	2.36	1.2 – 5.5
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	1.60	0.1 – 4.7
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	1.35	1.1 – 3.0
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	1.46	1.0 – 3.1

Tmax Hx-DR5-05 Cycle 2 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	3.12	1.1 – 5.1
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	2.19	1.0 – 3.5
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	1.19	1.0 – 1.4
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	2.26	1.2 – 5.1
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	2.31	1.1 – 3.3
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	2.21	1.2 – 3.2

Tmax Hx-DR5-05 Cycle 3 Day 1

Group	Value	95% CI
1. Biweekly Regimen (GEN1029 0.1 mg/kg)	1.08	0.0 – 1.5
2. Biweekly Regimen (GEN1029 0.2 mg/kg)	1.83	1.0 – 3.3
3. Biweekly Regimen (GEN1029 0.3 mg/kg)	1.18	1.1 – 1.3
4. Biweekly Regimen (GEN1029 1.0 mg/kg)	1.42	1.1 – 3.0
5. Biweekly Regimen (GEN1029 2.0 mg/kg)	1.13	1.0 – 1.8
6. Biweekly Regimen (GEN1029 3.0 mg/kg)	3.1	3.1 – 3.1

Plasma Concentration of Hx-DR5-01 and Hx-DR5-05 Secondary · Predose, end of infusion, 2, 4, 24, 48, 168 and 336 hours after end of infusion on Day 1 of Cycles 1, 2, 3

The plasma concentration of Hx-DR5-01 and Hx-DR5-05 are reported.

Plasma concentration Hx-DR5-01 Cycle 1 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.085	± 38.5
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.075	± 0.0

Plasma concentration Hx-DR5-01 Cycle 2 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.091	± 61.0
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.084	± 34.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.230	± 77.8
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.283	± 576.2

Plasma concentration Hx-DR5-01 Cycle 3 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.125	± 164.3
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.090	± 46.4
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.224	± 156.9
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.739	± NA

Plasma concentration Hx-DR5-05 Cycle 1 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.094	± 77.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.075	± 0.0

Plasma concentration Hx-DR5-05 Cycle 2 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.097	± 83.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.155	± 161.5
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.240	± 372.5

Plasma concentration Hx-DR5-05 Cycle 3 Day 1 (predose)

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	0.101	± 94.6
Biweekly Regimen (GEN1029 0.2 mg/kg)	0.119	± 138.5
Biweekly Regimen (GEN1029 0.3 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 1.0 mg/kg)	0.094	± 58.8
Biweekly Regimen (GEN1029 2.0 mg/kg)	0.075	± 0.0
Biweekly Regimen (GEN1029 3.0 mg/kg)	0.568	± NA

Number of Participants With Antidrug Antibodies (ADAs) Positive to GEN1029 Secondary · From Screening (Day -21 to -1) through Day 478 (corresponding to maximum observed duration)

From positive ADA samples titer values and neutralizing antibody scores (positive or negative) were determined and reported. A participant was considered positive if negative at baseline (screening) and had at least one positive post-baseline result, or positive at baseline and had at least one positive post-baseline result with a titer higher than baseline. Number of participants with ADA positive to GEN1029 are reported.

Group	Value	95% CI
Biweekly Regimen (GEN1029 0.1 mg/kg)	5
Biweekly Regimen (GEN1029 0.2 mg/kg)	5
Biweekly Regimen (GEN1029 0.3 mg/kg)	4
Biweekly Regimen (GEN1029 1.0 mg/kg)	7
Biweekly Regimen (GEN1029 2.0 mg/kg)	5
Biweekly Regimen (GEN1029 3.0 mg/kg)	0

Adverse events — posted to ClinicalTrials.gov

Time frame: For AEs: Day 1 through Day 565 (corresponding to maximum observed duration); and for All-cause mortality: From date of informed consent through Day 565 (corresponding to maximum observed duration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Biweekly Regimen (GEN1029 0.1 mg/kg)

Serious: 3/10 (30%)

Deaths: 3/10

Biweekly Regimen (GEN1029 0.2 mg/kg)

Serious: 3/7 (43%)

Deaths: 3/7

Biweekly Regimen (GEN1029 0.3 mg/kg)

Serious: 2/4 (50%)

Deaths: 1/4

Biweekly Regimen (GEN1029 1.0 mg/kg)

Serious: 9/11 (82%)

Deaths: 5/11

Biweekly Regimen (GEN1029 2.0 mg/kg)

Serious: 6/7 (86%)

Deaths: 4/7

Biweekly Regimen (GEN1029 3.0 mg/kg)

Serious: 4/7 (57%)

Deaths: 1/7

Priming Regimen (GEN1029 0.1 mg/kg)

Serious: 0/1 (0%)

Deaths: 0/1

Intensified Regimen (GEN1029 1.0 mg/kg)

Serious: 1/1 (100%)

Deaths: 1/1

Serious adverse events (32 terms)

Reaction	System	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Priming Regimen (GEN1029 0…	Intensified Regimen (GEN10…
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—
Sinus Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Gastrointestinal Inflammation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Large Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Small Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Hernia	General disorders	—	—	—	—	—	—	—	—
Drug-Induced Liver Injury	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Hepatitis	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Hyperbilirubinaemia	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Jaundice Cholestatic	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Anal Abscess	Infections and infestations	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—
Escherichia Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—
Lower Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—
Peritonitis	Infections and infestations	—	—	—	—	—	—	—	—

Other adverse events (131 terms — click to expand)

Reaction	System	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Biweekly Regimen (GEN1029 …	Priming Regimen (GEN1029 0…	Intensified Regimen (GEN10…
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—	—
Hypoalbuminaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—	—
Oedema	General disorders	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Hypophosphataemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Leukocytosis	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—
Ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Diarrhoea, Alanine Aminotransferase Increased, Malignant Neoplasm Progression, Pyrexia, Aspartate Aminotransferase Increased, Sinus Tachycardia, Abdominal Pain, Enteritis.

Data from ClinicalTrials.gov NCT03576131 adverse events section.

Sponsor's own description

The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting apoptosis in cancer therapy.
Carneiro BA, El-Deiry WS. · · 2020 · cited 1823× · PMID 32203277 · DOI 10.1038/s41571-020-0341-y
Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
Clinical promise of next-generation complement therapeutics.
Mastellos DC, Ricklin D, Lambris JD. · · 2019 · cited 255× · PMID 31324874 · DOI 10.1038/s41573-019-0031-6
Avidity in antibody effector functions and biotherapeutic drug design.
Oostindie SC, Lazar GA, Schuurman J, Parren PWHI. · · 2022 · cited 170× · PMID 35790857 · DOI 10.1038/s41573-022-00501-8
The TRAIL in the Treatment of Human Cancer: An Update on Clinical Trials.
Snajdauf M, Havlova K, Vachtenheim J, Ozaniak A, et al · · 2021 · cited 126× · PMID 33791337 · DOI 10.3389/fmolb.2021.628332
Antibody-mediated complement activation in pathology and protection.
Goldberg BS, Ackerman ME. · · 2020 · cited 86× · PMID 32142167 · DOI 10.1111/imcb.12324
Harnessing TRAIL-induced cell death for cancer therapy: a long walk with thrilling discoveries.
Montinaro A, Walczak H. · · 2023 · cited 83× · PMID 36195672 · DOI 10.1038/s41418-022-01059-z
The Role of TRAIL in Apoptosis and Immunosurveillance in Cancer.
Pimentel JM, Zhou JY, Wu GS. · · 2023 · cited 73× · PMID 37345089 · DOI 10.3390/cancers15102752

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Trials by the same sponsor.

NCT07416123 — A Study of GEN1106 in Participants With Solid Tumors · Phase 1 · recruiting
NCT07384715 — First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelod · Phase 1 · recruiting
NCT07288177 — Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · Phase 2 · recruiting
NCT06984328 — Study of the Effectiveness and Safety of Acasunlimab Alone and With Pembrolizumab to Treat Advanced Melanoma of the Skin · Phase 2 · active not recruiting
NCT06771921 — A First-in-Human Trial of Safety and Efficacy of GEN1078 in Participants With Solid Tumors · Phase 1, PHASE2 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03576131 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Genmab
Last refreshed: 1 August 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03576131.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing