NCT02988817 is a Phase 1, PHASE2 clinical trial of Enapotamab vedotin (HuMax-AXL-ADC) in Ovarian Cancer, sponsored by Genmab.

Who is sponsoring NCT02988817?

NCT02988817 is sponsored by Genmab.

What drugs are being tested in NCT02988817?

Interventions in NCT02988817: Enapotamab vedotin (HuMax-AXL-ADC).

What condition does NCT02988817 study?

NCT02988817 studies Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Non Small Cell Lung Cancer (NSCLC), Thyroid Cancer, Melanoma, Sarcoma, Solid Tumors.

Is NCT02988817 still recruiting?

NCT02988817 is currently completed. Last updated 1 August 2023.

Are results published for NCT02988817?

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

NCT02988817

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

Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors

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

What this trial tests

Phase 1, PHASE2 trial testing Enapotamab vedotin (HuMax-AXL-ADC) in Ovarian Cancer in 306 participants. Completed in 12 November 2021.

Timeline

23 November 2016

Primary endpoint
12 November 2021

12 November 2021

Quick facts

Lead sponsor	Genmab
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	306
Start date	23 November 2016
Primary completion	12 November 2021
Estimated completion	12 November 2021
Sites	41 locations across Denmark, Netherlands, Belgium, United Kingdom, United States, Spain

Drugs / interventions tested

Enapotamab vedotin (HuMax-AXL-ADC) — full drug profile →

Conditions studied

Ovarian Cancer — all drugs for Ovarian Cancer →
Cervical Cancer — all drugs for Cervical Cancer →
Endometrial Cancer — all drugs for Endometrial Cancer →
Non Small Cell Lung Cancer (NSCLC) — all drugs for Non Small Cell Lung Cancer (NSCLC) →

Sponsor

Genmab — full company profile →

Who can join

18 and older, any sex, with Ovarian Cancer or Cervical 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) for Dose-escalation Part Primary · From Day 1 to Day 21 of first cycle for 1Q3W dosing regimen and from Day 1 to Day 28 of first cycle for 3Q4W dosing regimen

The DLTs were defined as Grade (G) 4 neutropenia or G4 thrombocytopenia for a minimal duration of 7 days, G3 and G4 febrile neutropenia, \>=G3 hemorrhage associated with \>=G3 thrombocytopenia, G4 anemia; Stevens Johnson syndrome, toxic epidermal necrolysis, \>=G3 cutaneous vasculitis; G3 neuropathy (not improved to G1 within 3 weeks following pausing of dosing) and G4 neuropathy; G3 infusion-related reactions (IRR) that did not resolve to G1 or baseline within 24 hours; G4 IRR or G4 anaphylaxis events; \>= G3 diarrhoea and/or vomiting persisting \>48 hours or G3 nausea lasting 7 days (both de

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	2
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	2

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) Primary · Day 1 through Day 1130 (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: requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, is a congenital anomaly/birth defect, is medically important, results in death, or is life-threatening. In this trial, a TEAE was defined as an AE occurring or worsening betwee

Any TEAE

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	11
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W	22

Any TESAE

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	2
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	7
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	6
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	2
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	1
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	2
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W	15

Number of Participants With Treatment-emergent Infusion-related AEs and TEAEs Related to Enapotamab Vedotin Primary · Day 1 through Day 1130 (maximum observed duration)

Number of participants with treatment-emergent infusion-related AEs and TEAEs related to enapotamab vedotin is reported.

Treatment emergent infusion-related AEs

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	2
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	1
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	0
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W	0

TEAEs related to enapotamab vedotin

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	10
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	10
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	3
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	6
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W	21

Number of Participants With >= Grade 3 TEAEs as Assessed by National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 Primary · Day 1 through Day 1130 (maximum observed duration)

Number of participants with TEAEs of \>= Grade 3 as assessed by NCI-CTCAE v4.03 is 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. If a participant reported multiple severity grades for an AE, only the maximum grade was used.

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	2
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	7
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	9
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	3
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	1
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	0
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	3
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	3
Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W	15

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part Secondary · Predose, end of infusion (EOI), and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3

The AUC0-inf of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	6.143	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	13.233	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	18.353	± 8.6
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	40.921	± 27.7
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	64.140	± 13.2
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	67.998	± 32.2
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	76.264	± 31.7

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	5.780	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	10.892	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	18.664	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	39.589	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	56.842	± 23.8
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	61.161	± 10.7

Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Conjugated Enapotamab Vedotin for 1Q3W Dose-escalation Part Secondary · Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3

The AUC0-last of conjugated enapotamab vedotin for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	5.509	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	10.369	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	16.004	± 18.5
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	36.526	± 29.7
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	58.410	± 11.6
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	62.563	± 29.7
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	71.196	± 32.5

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	5.306	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	9.157	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	15.047	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	36.333	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	51.541	± 21.4
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	57.759	± 11.9

Maximum Observed Plasma Concentration (Cmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part Secondary · For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose and EOI on Days 1 and 8 of Cycles 1 and 3; and predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

The Cmax of conjugated enapotamab vedotin for dose-escalation part is reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	7.250	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	12.600	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	16.615	± 16.7
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	33.005	± 9.4
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	39.647	± 11.4
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	43.377	± 25.6
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	48.548	± 33.0
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	10.127	± 40.2
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	14.307	± 31.6
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	18.040	± 12.0
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	17.928	± 22.0

Cycle 1 Day 8

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	14.201	± 11.9
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	16.765	± 36.3
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	18.698	± 8.1
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	18.958	± 19.5

Cycle 1 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	13.172	± 8.0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	16.166	± 37.2
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	16.991	± 7.8
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	18.500	± NA

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	6.870	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	11.000	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	16.200	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	32.400	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	35.890	± 17.9
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	38.928	± 9.0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	22.400	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	21.800	± NA

Cycle 3 Day 8

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	21.200	± NA

Cycle 3 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	24.100	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	22.800	± NA

Total Clearance (CL) of Conjugated Enapotamab Vedotin in Dose-escalation Part Secondary · For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

The total CL of conjugated enapotamab vedotin in dose-escalation part is reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	4.053	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	3.446	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	3.538	± 21.8
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	2.307	± 28.3
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	2.202	± 22.2
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	2.205	± 25.4
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	1.783	± 24.3

Cycle 1 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	3.679	± 9.4
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	3.084	± 93.8
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	3.402	± 31.3
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	2.629	± NA

Cycle 3 day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	4.360	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	4.187	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	3.000	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	2.160	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	2.285	± 27.1
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	2.539	± 14.7

Cycle 3 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	2.281	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	3.412	± NA

Time of Maximum Plasma Concentration (Tmax) of Conjugated Enapotamab Vedotin for Dose-escalation Part Secondary · For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

The Tmax of conjugated enapotamab vedotin for dose-escalation part is reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0.06	0.06 – 0.06
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0.03	0.03 – 0.03
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0.036	0.03 – 0.04
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	0.033	0.03 – 0.04
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	0.032	0.02 – 0.09
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	0.032	0.02 – 0.04
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	0.03	0.02 – 0.03

Cycle 1 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	14.010	13.96 – 14.88
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	14.058	13.98 – 14.08
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	14.083	14.00 – 14.19
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	13.98	13.98 – 13.98

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0.04	0.04 – 0.04
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	0.03	0.03 – 0.03
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	0.04	0.04 – 0.04
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	0.030	0.03 – 0.03
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	0.036	0.02 – 0.05
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	0.042	0.03 – 0.11

Cycle 3 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	14.02	14.02 – 14.02
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	13.98	13.98 – 13.98

Half-life Lambda-z (t1/2) of Conjugated Enapotamab Vedotin for Dose-escalation Part Secondary · For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

The t1/2 of conjugated enapotamab vedotin for dose-escalation part is reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0.87	0.87 – 0.87
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	1.49	1.49 – 1.49
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	1.362	1.02 – 1.39
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	1.384	1.19 – 1.65
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	2.004	1.67 – 2.53
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	1.810	1.53 – 2.74
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	2.153	1.99 – 2.60

Cycle 1 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	1.097	0.66 – 1.56
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	1.398	0.91 – 1.81
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	1.423	0.77 – 1.96
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	2.05	2.05 – 2.05

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	0.78	0.78 – 0.78
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	1.07	1.07 – 1.07
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	1.130	1.13 – 1.13
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	1.68	1.68 – 1.68
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	2.117	1.55 – 2.90
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	2.035	1.38 – 2.74

Cycle 3 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	1.51	1.51 – 1.51
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	1.44	1.44 – 1.44

Volume of Distribution at Steady State (Vss) of Conjugated Enapotamab Vedotin for Dose-escalation Part Secondary · For 1Q3W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3; For 3Q4W dosing regimen: Predose, EOI, and 2 and 5 hours after EOI on Day 15 of Cycles 1 and 3

The Vss of conjugated enapotamab vedotin for dose-escalation part is reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	4.909	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	6.544	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	5.873	± 9.8
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	4.208	± 12.5
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	6.028	± 18.4
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	5.489	± 24.2
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	5.038	± 27.3

Cycle 1 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W	57.736	± 10.0
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	48.001	± 91.1
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	53.436	± 28.0
Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W	42.708	± NA

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	4.755	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	6.288	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	4.870	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	4.534	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	6.072	± 24.2
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	6.656	± 22.0

Cycle 3 Day 15

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W	36.476	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W	53.085	± NA

AUC0-inf of Free Toxin Monomethyl Auristatin E (MMAE) for 1Q3W Dose-escalation Part Secondary · Predose, EOI, and 2 and 5 hours after EOI on Day 1 of Cycles 1 and 3

The AUC0-inf of MMAE for 1Q3W dose-escalation part is reported. Sample scheduling of the 3Q4W dosing regimen did not allow calculation of the specific outcome measure.

Cycle 1 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	3832.48	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	6144.11	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	13673.7	± 110.4
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	26549.1	± 82.9
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	33494.5	± 47.1
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	50459.6	± 117.0
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	48626.4	± 95.5

Cycle 3 Day 1

Group	Value	95% CI
Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W	3248.46	± NA
Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W	7452.05	± NA
Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W	4338.20	± NA
Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W	47093.9	± NA
Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W	30512.0	± 47.8
Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W	34188.6	± 46.6
Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W	16754.5	± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: For TEAEs: Day 1 through Day 1130 and for all-cause mortality: From date of inform consent form until death (up to 44.5 months) (maximum observed duration). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose-escalation Part: Enapotamab Vedotin 0.3 mg/kg 1Q3W

Serious: 0/1 (0%)

Deaths: 0/1

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 1Q3W

Serious: 0/1 (0%)

Deaths: 1/1

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 1Q3W

Serious: 0/3 (0%)

Deaths: 3/3

Dose-escalation Part: Enapotamab Vedotin 1.5 mg/kg 1Q3W

Serious: 2/3 (67%)

Deaths: 1/3

Dose-escalation Part: Enapotamab Vedotin 2.0 mg/kg 1Q3W

Serious: 7/10 (70%)

Deaths: 6/10

Dose-escalation Part: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 6/11 (55%)

Deaths: 10/11

Dose-escalation Part: Enapotamab Vedotin 2.4 mg/kg 1Q3W

Serious: 2/3 (67%)

Deaths: 1/3

Dose-escalation Part: Enapotamab Vedotin 0.6 mg/kg 3Q4W

Serious: 1/3 (33%)

Deaths: 2/3

Dose-escalation Part: Enapotamab Vedotin 0.8 mg/kg 3Q4W

Serious: 0/3 (0%)

Deaths: 1/3

Dose-escalation Part: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Serious: 2/6 (33%)

Deaths: 5/6

Dose-escalation Part: Enapotamab Vedotin 1.2 mg/kg 3Q4W

Serious: 3/3 (100%)

Deaths: 1/3

Expansion Part Cohort 1: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 15/22 (68%)

Deaths: 8/22

Expansion Part Cohort 3: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 5/16 (31%)

Deaths: 9/16

Expansion Part Cohort 4: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 16/25 (64%)

Deaths: 17/25

Expansion Part Cohort 5: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 10/25 (40%)

Deaths: 18/25

Expansion Part Cohort 6: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Serious: 16/44 (36%)

Deaths: 30/44

Expansion Part Cohort 7: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 12/25 (48%)

Deaths: 17/25

Expansion Part Cohort 2: Enapotamab Vedotin 2.2 mg/kg 1Q3W

Serious: 33/56 (59%)

Deaths: 38/56

Expansion Part Cohort 2: Enapotamab Vedotin 1.8 mg/kg 1Q3W

Serious: 7/20 (35%)

Deaths: 14/22

Expansion Part Cohort 8: Enapotamab Vedotin 1.0 mg/kg 3Q4W

Serious: 14/26 (54%)

Deaths: 16/26

Serious adverse events (103 terms)

Reaction	System	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Expansion Part Cohort 1: E…	Expansion Part Cohort 3: E…	Expansion Part Cohort 4: E…	Expansion Part Cohort 5: E…	Expansion Part Cohort 6: E…	Expansion Part Cohort 7: E…	Expansion Part Cohort 2: E…	Expansion Part Cohort 2: E…	Expansion Part Cohort 8: E…
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malignant Neoplasm Progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
General Physical Health Deterioration	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small Intestinal Obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lower Respiratory Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Septic Shock	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral Sensorimotor Neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pneumonitis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Febrile Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Atrial Fibrillation	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (404 terms — click to expand)

Reaction	System	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Dose-escalation Part: Enap…	Expansion Part Cohort 1: E…	Expansion Part Cohort 3: E…	Expansion Part Cohort 4: E…	Expansion Part Cohort 5: E…	Expansion Part Cohort 6: E…	Expansion Part Cohort 7: E…	Expansion Part Cohort 2: E…	Expansion Part Cohort 2: E…	Expansion Part Cohort 8: E…
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased Appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight Decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal Pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral Sensory Neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine Aminotransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back Pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary Tract Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood Alkaline Phosphatase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gamma-glutamyltransferase Increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry Mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oral Candidiasis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pain in Extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neuropathy Peripheral	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Restless Legs Syndrome	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Constipation, Nausea, Pneumonia, Malignant Neoplasm Progression, Pulmonary Embolism, Colitis, Vomiting, General Physical Health Deterioration.

Data from ClinicalTrials.gov NCT02988817 adverse events section.

Sponsor's own description

The purpose of the trial is to determine the maximum tolerated dose and to establish the safety profile of HuMax-AXL-ADC in a mixed population of patients with specified solid tumors

Publications & conference data

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

Next generation of immune checkpoint inhibitors and beyond.
Marin-Acevedo JA, Kimbrough EO, Lou Y. · · 2021 · cited 401× · PMID 33741032 · DOI 10.1186/s13045-021-01056-8
Antibody-Drug Conjugates for Cancer Therapy.
Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
Emerging therapeutic agents for advanced non-small cell lung cancer.
Chen R, Manochakian R, James L, Azzouqa AG, et al · · 2020 · cited 244× · PMID 32448366 · DOI 10.1186/s13045-020-00881-7
Precision medicine for human cancers with Notch signaling dysregulation (Review).
Katoh M, Katoh M. · · 2020 · cited 159× · PMID 31894255 · DOI 10.3892/ijmm.2019.4418
Targeting cancer with antibody-drug conjugates: Promises and challenges.
Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6
Antibody structure and engineering considerations for the design and function of Antibody Drug Conjugates (ADCs).
Hoffmann RM, Coumbe BGT, Josephs DH, Mele S, et al · · 2018 · cited 134× · PMID 29375935 · DOI 10.1080/2162402x.2017.1395127
Current Advances in the Treatment of BRAF-Mutant Melanoma.
Patel H, Yacoub N, Mishra R, White A, et al · · 2020 · cited 133× · PMID 32092958 · DOI 10.3390/cancers12020482

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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 NCT02988817 (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/NCT02988817.

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

NCT02988817

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (103 terms)

Sponsor's own description

Publications & conference data

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