NCT02001623 is a Phase 1, PHASE2 clinical trial of Tisotumab Vedotin (HuMax-TF-ADC) in Ovary Cancer, sponsored by Seagen Inc..

Who is sponsoring NCT02001623?

NCT02001623 is sponsored by Seagen Inc..

What drugs are being tested in NCT02001623?

Interventions in NCT02001623: Tisotumab Vedotin (HuMax-TF-ADC).

What condition does NCT02001623 study?

NCT02001623 studies Ovary Cancer, Cervix Cancer, Endometrium Cancer, Bladder Cancer, Prostate Cancer (CRPC), Esophagus Cancer, Lung Cancer(NSCLC), Squamous Cell Carcinoma of the Head and Neck (SCCHN).

Is NCT02001623 still recruiting?

NCT02001623 is currently completed. Last updated 29 December 2021.

Are results published for NCT02001623?

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

Last reviewed 2021-12-29 · How we verify

NCT02001623

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

Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors

Completed Phase 1, PHASE2 Results posted Last updated 29 December 2021

What this trial tests

Phase 1, PHASE2 trial testing Tisotumab Vedotin (HuMax-TF-ADC) in Ovary Cancer in 195 participants. Completed in 2 May 2019.

Timeline

30 November 2013

Primary endpoint
2 May 2019

2 May 2019

Quick facts

Lead sponsor	Seagen Inc.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	195
Start date	30 November 2013
Primary completion	2 May 2019
Estimated completion	2 May 2019
Sites	29 locations across Denmark, Belgium, Sweden, United Kingdom, United States

Drugs / interventions tested

Tisotumab Vedotin (HuMax-TF-ADC) — full drug profile →

Conditions studied

Ovary Cancer — all drugs for Ovary Cancer →
Cervix Cancer — all drugs for Cervix Cancer →
Endometrium Cancer — all drugs for Endometrium Cancer →
Bladder Cancer — all drugs for Bladder Cancer →

Sponsor

Seagen Inc. — full company profile →

Who can join

18 and older, any sex, with Ovary Cancer or Cervix 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.

Dose Escalation Part: Evaluation of Treatment-Emergent Adverse Events Primary · Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the dose escalation part.

Evaluation of treatment-emergent adverse events (TEAEs) includes number of participants with at least one: TEAE Serious TEAE Infusion-related TEAE Common Terminology Criteria for Adverse Events (CTCAE) grade \>=3 Treatment-related TEAE A CTCAE TEAE was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of

TEAEs

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	3
Dose Escalation Part: 0.6 mg/kg	3
Dose Escalation Part: 0.9 mg/kg	3
Dose Escalation Part: 1.2 mg/kg	3
Dose Escalation Part: 1.5 mg/kg	3
Dose Escalation Part: 1.8 mg/kg	3
Dose Escalation Part: 2.0 mg/kg	3
Dose Escalation Part: 2.2 mg/kg	6

Serious TEAEs

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2
Dose Escalation Part: 0.6 mg/kg	1
Dose Escalation Part: 0.9 mg/kg	0
Dose Escalation Part: 1.2 mg/kg	2
Dose Escalation Part: 1.5 mg/kg	2
Dose Escalation Part: 1.8 mg/kg	2
Dose Escalation Part: 2.0 mg/kg	2
Dose Escalation Part: 2.2 mg/kg	4

Infusion-Related TEAEs

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	1
Dose Escalation Part: 0.6 mg/kg	0
Dose Escalation Part: 0.9 mg/kg	0
Dose Escalation Part: 1.2 mg/kg	0
Dose Escalation Part: 1.5 mg/kg	0
Dose Escalation Part: 1.8 mg/kg	0
Dose Escalation Part: 2.0 mg/kg	0
Dose Escalation Part: 2.2 mg/kg	0

CTCAE Grade >=3 TEAEs

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2
Dose Escalation Part: 0.6 mg/kg	3
Dose Escalation Part: 0.9 mg/kg	1
Dose Escalation Part: 1.2 mg/kg	1
Dose Escalation Part: 1.5 mg/kg	2
Dose Escalation Part: 1.8 mg/kg	3
Dose Escalation Part: 2.0 mg/kg	2
Dose Escalation Part: 2.2 mg/kg	4

TEAEs Related to Study Drug

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	3
Dose Escalation Part: 0.6 mg/kg	3
Dose Escalation Part: 0.9 mg/kg	2
Dose Escalation Part: 1.2 mg/kg	3
Dose Escalation Part: 1.5 mg/kg	3
Dose Escalation Part: 1.8 mg/kg	3
Dose Escalation Part: 2.0 mg/kg	3
Dose Escalation Part: 2.2 mg/kg	6

Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Hematology Values Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Number of participants with markedly abnormal hematology values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 hematology value. A markedly abnormal hematology value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequences;

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2
Dose Escalation Part: 0.6 mg/kg	1
Dose Escalation Part: 0.9 mg/kg	1
Dose Escalation Part: 1.2 mg/kg	0
Dose Escalation Part: 1.5 mg/kg	2
Dose Escalation Part: 1.8 mg/kg	2
Dose Escalation Part: 2.0 mg/kg	0
Dose Escalation Part: 2.2 mg/kg	1
Dose Expansion Part: Bladder Cancer	0
Dose Expansion Part: Cervical Cancer	23
Dose Expansion Part: Endometrial Cancer	0
Dose Expansion Part: Esophageal Cancer	3

Dose Escalation and Expansion Parts: Number of Participants With Markedly Abnormal Coagulation Values Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Number of participants with markedly abnormal coagulation values was defined as all participants who experienced at least 1 CTCAE grade \>= 3 coagulation value. A markedly abnormal coagulation value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening consequenc

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	0
Dose Escalation Part: 0.6 mg/kg	0
Dose Escalation Part: 0.9 mg/kg	0
Dose Escalation Part: 1.2 mg/kg	0
Dose Escalation Part: 1.5 mg/kg	0
Dose Escalation Part: 1.8 mg/kg	0
Dose Escalation Part: 2.0 mg/kg	0
Dose Escalation Part: 2.2 mg/kg	1
Dose Expansion Part: Bladder Cancer	1
Dose Expansion Part: Cervical Cancer	7
Dose Expansion Part: Endometrial Cancer	2
Dose Expansion Part: Esophageal Cancer	0

Dose Escalation and Expansion Part: Number of Participants With Markedly Abnormal Biochemistry Values Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Number of participants with markedly abnormal biochemistry results were defined as all participants who experienced at least 1 CTCAE grade \>= 3 biochemistry value. A markedly abnormal biochemistry value was determined using the CTCAE grading systems based on National Cancer Institute (NCI)-CTCAE version 4.03 assessed by the investigator per the below definitions. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living. Grade 4: Life-threatening conse

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2
Dose Escalation Part: 0.6 mg/kg	1
Dose Escalation Part: 0.9 mg/kg	3
Dose Escalation Part: 1.2 mg/kg	0
Dose Escalation Part: 1.5 mg/kg	1
Dose Escalation Part: 1.8 mg/kg	0
Dose Escalation Part: 2.0 mg/kg	1
Dose Escalation Part: 2.2 mg/kg	2
Dose Expansion Part: Bladder Cancer	4
Dose Expansion Part: Cervical Cancer	8
Dose Expansion Part: Endometrial Cancer	4
Dose Expansion Part: Esophageal Cancer	6

Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Skin Rash Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	1
Dose Escalation Part: 0.6 mg/kg	0
Dose Escalation Part: 0.9 mg/kg	0
Dose Escalation Part: 1.2 mg/kg	2
Dose Escalation Part: 1.5 mg/kg	0
Dose Escalation Part: 1.8 mg/kg	2
Dose Escalation Part: 2.0 mg/kg	2
Dose Escalation Part: 2.2 mg/kg	4
Dose Expansion Part: Bladder Cancer	3
Dose Expansion Part: Cervical Cancer	6
Dose Expansion Part: Endometrial Cancer	2
Dose Expansion Part: Esophageal Cancer	2

Dose Escalation and Expansion Parts: Number of Participants Who Experienced a Bleeding Event of Special Interest Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Bleeding adverse events of special interest included treatment emergent adverse events with preferred terms within the following standardised MedDRA queries (SMQs): Haemorrhage terms, excluding laboratory terms SMQ \[20000039\] (Broad) and Haemorrhage, laboratory terms SMQ \[20000040\] (Narrow). Bleeding adverse events of special interest were evaluated according to the NCI-CTCAE version 4.03. Bleeding events of all grades are included. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noni

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	0
Dose Escalation Part: 0.6 mg/kg	1
Dose Escalation Part: 0.9 mg/kg	0
Dose Escalation Part: 1.2 mg/kg	3
Dose Escalation Part: 1.5 mg/kg	3
Dose Escalation Part: 1.8 mg/kg	3
Dose Escalation Part: 2.0 mg/kg	2
Dose Escalation Part: 2.2 mg/kg	5
Dose Expansion Part: Bladder Cancer	10
Dose Expansion Part: Cervical Cancer	31
Dose Expansion Part: Endometrial Cancer	10
Dose Expansion Part: Esophageal Cancer	7

Dose Escalation and Expansion Part: Number of Participants Who Experienced a Peripheral Neuropathy Event Secondary · Day 1 to end of follow-up, up to a maximum of 60 weeks

Peripheral neuropathy events of special interest were evaluated according to the NCI-CTCAE version 4.03. Peripheral neuropathy events of all grades are included in the numbers below. Grade 1:Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	0
Dose Escalation Part: 0.6 mg/kg	1
Dose Escalation Part: 0.9 mg/kg	1
Dose Escalation Part: 1.2 mg/kg	1
Dose Escalation Part: 1.5 mg/kg	0
Dose Escalation Part: 1.8 mg/kg	1
Dose Escalation Part: 2.0 mg/kg	0
Dose Escalation Part: 2.2 mg/kg	1
Dose Expansion Part: Bladder Cancer	5
Dose Expansion Part: Cervical Cancer	17
Dose Expansion Part: Endometrial Cancer	6
Dose Expansion Part: Esophageal Cancer	3

Dose Escalation Part: Clearance of Tisotumab Vedotin and Total HuMax-TF Secondary · Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)

Pharmacokinetic (PK) parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not collected to report or calculate clearance for the expansion phase.

Tisotumab Vedotin: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	1.61	± 7.79
Dose Escalation Part: 0.9 mg/kg	1.46	± 15.23
Dose Escalation Part: 1.2 mg/kg	1.07	± 11.60
Dose Escalation Part: 1.5 mg/kg	1.84	± 20.59
Dose Escalation Part: 1.8 mg/kg	1.17	± 60.05
Dose Escalation Part: 2.0 mg/kg	1.56	± 34.12
Dose Escalation Part: 2.2 mg/kg	0.87	± 8.93

Tisotumab Vedotin: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	1.72	± 4.98
Dose Escalation Part: 0.9 mg/kg	1.44	± 6.32
Dose Escalation Part: 1.2 mg/kg	1.07	± 10.45
Dose Escalation Part: 1.5 mg/kg	2.05	± 26.80
Dose Escalation Part: 1.8 mg/kg	0.93	± 24.03
Dose Escalation Part: 2.0 mg/kg	1.30	± 19.06
Dose Escalation Part: 2.2 mg/kg	1.03	± 11.34

Total HuMax-TF: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	1.02	± 0.20
Dose Escalation Part: 0.9 mg/kg	0.98	± 16.90
Dose Escalation Part: 1.2 mg/kg	0.69	± 12.61
Dose Escalation Part: 1.5 mg/kg	1.26	± 31.29
Dose Escalation Part: 1.8 mg/kg	0.81	± 69.72
Dose Escalation Part: 2.0 mg/kg	0.87	± 33.85
Dose Escalation Part: 2.2 mg/kg	0.56	± 14.13

Total HuMax-TF: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	1.05	± 9.95
Dose Escalation Part: 0.9 mg/kg	0.98	± 6.52
Dose Escalation Part: 1.2 mg/kg	0.71	± 13.41
Dose Escalation Part: 1.5 mg/kg	1.40	± 31.39
Dose Escalation Part: 1.8 mg/kg	0.53	± 12.41
Dose Escalation Part: 2.0 mg/kg	0.82	± 26.45
Dose Escalation Part: 2.2 mg/kg	0.61	± 9.72

Dose Escalation Part: Volume of Distribution of Tisotumab Vedotin and Total HuMax-TF Secondary · Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)

PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study. Data was not planned to be collected for the volume of distribution of tisotumab vedotin and total HuMax-TF for the dose expansion part.

Tisotumab Vedotin: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	68.40	± 11.84
Dose Escalation Part: 0.9 mg/kg	70.80	± 14.54
Dose Escalation Part: 1.2 mg/kg	63.46	± 16.87
Dose Escalation Part: 1.5 mg/kg	86.10	± 12.38
Dose Escalation Part: 1.8 mg/kg	81.13	± 35.60
Dose Escalation Part: 2.0 mg/kg	92.04	± 21.62
Dose Escalation Part: 2.2 mg/kg	61.46	± 18.07

Tisotumab Vedotin: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	76.69	± 9.53
Dose Escalation Part: 0.9 mg/kg	69.74	± 7.99
Dose Escalation Part: 1.2 mg/kg	62.61	± 6.03
Dose Escalation Part: 1.5 mg/kg	99.20	± 20.82
Dose Escalation Part: 1.8 mg/kg	70.21	± 42.93
Dose Escalation Part: 2.0 mg/kg	74.82	± 4.19
Dose Escalation Part: 2.2 mg/kg	72.74	± 5.79

Total HuMax-TF: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	51.55	± 1.61
Dose Escalation Part: 0.9 mg/kg	60.27	± 17.79
Dose Escalation Part: 1.2 mg/kg	57.38	± 8.65
Dose Escalation Part: 1.5 mg/kg	77.55	± 10.74
Dose Escalation Part: 1.8 mg/kg	67.26	± 50.61
Dose Escalation Part: 2.0 mg/kg	68.69	± 30.52
Dose Escalation Part: 2.2 mg/kg	50.69	± 7.20

Total HuMax-TF: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	55.75	± 10.80
Dose Escalation Part: 0.9 mg/kg	57.13	± 8.90
Dose Escalation Part: 1.2 mg/kg	58.48	± 12.66
Dose Escalation Part: 1.5 mg/kg	84.98	± 22.85
Dose Escalation Part: 1.8 mg/kg	50.62	± 36.02
Dose Escalation Part: 2.0 mg/kg	60.40	± 17.48
Dose Escalation Part: 2.2 mg/kg	58.10	± 12.31

Dose Escalation and Expansion Part: Area Under the Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Tisotumab Vedotin and Total HuMax-TF Secondary · Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)

PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.

Tisotumab Vedotin: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2.5	± 3.1
Dose Escalation Part: 0.6 mg/kg	15.4	± 8.2
Dose Escalation Part: 0.9 mg/kg	25.1	± 16.9
Dose Escalation Part: 1.2 mg/kg	45.2	± 9.3
Dose Escalation Part: 1.5 mg/kg	33.1	± 19.0
Dose Escalation Part: 1.8 mg/kg	63.0	± 49.3
Dose Escalation Part: 2.0 mg/kg	52.3	± 33.1
Dose Escalation Part: 2.2 mg/kg	84.9	± 33.7
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	79.31	± 49.40

Tisotumab Vedotin: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2.0	± 15.7
Dose Escalation Part: 0.6 mg/kg	9.9	± 49.1
Dose Escalation Part: 0.9 mg/kg	25.6	± 7.1
Dose Escalation Part: 1.2 mg/kg	45.2	± 10.1
Dose Escalation Part: 1.5 mg/kg	29.8	± 25.1
Dose Escalation Part: 1.8 mg/kg	42.7	± 72.7
Dose Escalation Part: 2.0 mg/kg	62.7	± 21.5
Dose Escalation Part: 2.2 mg/kg	86.3	± 14.4
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	68.54	± 55.49

Total HuMax-TF: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2.9	± 0.5
Dose Escalation Part: 0.6 mg/kg	15.4	± 53.1
Dose Escalation Part: 0.9 mg/kg	35.0	± 18.9
Dose Escalation Part: 1.2 mg/kg	60.4	± 13.4
Dose Escalation Part: 1.5 mg/kg	44.9	± 27.8
Dose Escalation Part: 1.8 mg/kg	86.7	± 54.3
Dose Escalation Part: 2.0 mg/kg	85.9	± 36.7
Dose Escalation Part: 2.2 mg/kg	123.0	± 34.7
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	112.70	± 45.23

Total HuMax-TF: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	2.4	± 12.3
Dose Escalation Part: 0.6 mg/kg	14.4	± 55.4
Dose Escalation Part: 0.9 mg/kg	35.7	± 7.1
Dose Escalation Part: 1.2 mg/kg	58.8	± 15.5
Dose Escalation Part: 1.5 mg/kg	40.9	± 26.2
Dose Escalation Part: 1.8 mg/kg	60.2	± 76.6
Dose Escalation Part: 2.0 mg/kg	92.5	± 33.4
Dose Escalation Part: 2.2 mg/kg	133.6	± 13.9
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	114.54	± 45.83

Dose Escalation Part: Area Under the Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Tisotumab Vedotin and Total HuMax-TF Secondary · Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)

PK parameters in plasma were determined based on non compartmental methods and calculated separately for Cycle 1 and Cycle 2. AUC0-inf was only analyzed in the dose escalation part of the study. Data was not planned to be collected for the AUC0-inf of tisotumab vedotin and total HuMax-TF for the dose expansion part.

Tisotumab Vedotin: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	15.57	± 7.81
Dose Escalation Part: 0.9 mg/kg	25.77	± 15.70
Dose Escalation Part: 1.2 mg/kg	46.68	± 10.99
Dose Escalation Part: 1.5 mg/kg	33.95	± 20.93
Dose Escalation Part: 1.8 mg/kg	63.88	± 48.61
Dose Escalation Part: 2.0 mg/kg	53.47	± 30.88
Dose Escalation Part: 2.2 mg/kg	105.84	± 8.68

Tisotumab Vedotin: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	14.52	± 4.98
Dose Escalation Part: 0.9 mg/kg	26.12	± 6.44
Dose Escalation Part: 1.2 mg/kg	46.59	± 9.98
Dose Escalation Part: 1.5 mg/kg	30.56	± 26.43
Dose Escalation Part: 1.8 mg/kg	80.59	± 24.03
Dose Escalation Part: 2.0 mg/kg	64.10	± 19.06
Dose Escalation Part: 2.2 mg/kg	88.95	± 11.04

Total HuMax-TF: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	23.75	± 0.20
Dose Escalation Part: 0.9 mg/kg	37.02	± 16.39
Dose Escalation Part: 1.2 mg/kg	69.96	± 13.26
Dose Escalation Part: 1.5 mg/kg	48.19	± 35.67
Dose Escalation Part: 1.8 mg/kg	90.08	± 52.74
Dose Escalation Part: 2.0 mg/kg	93.29	± 30.45
Dose Escalation Part: 2.2 mg/kg	157.81	± 12.70

Total HuMax-TF: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.6 mg/kg	23.01	± 9.95
Dose Escalation Part: 0.9 mg/kg	37.08	± 6.37
Dose Escalation Part: 1.2 mg/kg	67.93	± 14.25
Dose Escalation Part: 1.5 mg/kg	43.41	± 30.31
Dose Escalation Part: 1.8 mg/kg	136.08	± 12.41
Dose Escalation Part: 2.0 mg/kg	98.59	± 26.45
Dose Escalation Part: 2.2 mg/kg	145.82	± 9.42

Dose Escalation and Expansion Part: Maximum Observed Plasma Concentration (Cmax) of Tisotumab Vedotin and Total HuMax-TF Secondary · Before infusion, Day 1 (pre-dose) and 0.25 to 336 hours post-dose of Cycle 1 and Cycle 2 (each cycle was 21 days)

PK parameters in plasma were determined based on non-compartmental methods and calculated separately for Cycle 1 and Cycle 2 in each part of the study.

Tisotumab Vedotin: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	4.78	± 12.35
Dose Escalation Part: 0.6 mg/kg	12.20	± 9.47
Dose Escalation Part: 0.9 mg/kg	19.81	± 17.32
Dose Escalation Part: 1.2 mg/kg	34.67	± 18.48
Dose Escalation Part: 1.5 mg/kg	23.12	± 21.10
Dose Escalation Part: 1.8 mg/kg	35.42	± 39.20
Dose Escalation Part: 2.0 mg/kg	32.30	± 22.08
Dose Escalation Part: 2.2 mg/kg	55.53	± 10.31
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	29.1	± 34.1

Tisotumab Vedotin: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	3.85	± 27.65
Dose Escalation Part: 0.6 mg/kg	12.51	± 11.51
Dose Escalation Part: 0.9 mg/kg	20.25	± 5.14
Dose Escalation Part: 1.2 mg/kg	32.38	± 7.11
Dose Escalation Part: 1.5 mg/kg	21.84	± 24.97
Dose Escalation Part: 1.8 mg/kg	35.92	± 30.39
Dose Escalation Part: 2.0 mg/kg	44.30	± 0.32
Dose Escalation Part: 2.2 mg/kg	48.79	± 26.37
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	26.1	± 41.2

Total HuMax-TF: Cycle 1

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	4.90	± 13.00
Dose Escalation Part: 0.6 mg/kg	11.84	± 8.31
Dose Escalation Part: 0.9 mg/kg	17.98	± 11.64
Dose Escalation Part: 1.2 mg/kg	29.30	± 10.14
Dose Escalation Part: 1.5 mg/kg	23.55	± 25.16
Dose Escalation Part: 1.8 mg/kg	30.57	± 37.42
Dose Escalation Part: 2.0 mg/kg	38.78	± 21.77
Dose Escalation Part: 2.2 mg/kg	58.02	± 12.77
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	39.8	± 31.1

Total HuMax-TF: Cycle 2

Group	Value	95% CI
Dose Escalation Part: 0.3 mg/kg	3.96	± 21.83
Dose Escalation Part: 0.6 mg/kg	11.54	± 8.83
Dose Escalation Part: 0.9 mg/kg	16.90	± 1.57
Dose Escalation Part: 1.2 mg/kg	31.33	± 8.13
Dose Escalation Part: 1.5 mg/kg	22.11	± 21.03
Dose Escalation Part: 1.8 mg/kg	37.71	± 42.96
Dose Escalation Part: 2.0 mg/kg	43.40	± 6.67
Dose Escalation Part: 2.2 mg/kg	53.67	± 19.75
Dose Expansion Part: Pharmacokinetics (PK) Analysis Set	38.3	± 33.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events are reported from Day 1 to 30 days after dosing. The treatment duration ranged from 1 to 249 days in the escalation part and from 1 to 325 days in the expansion part.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Escalation Part: 0.3 mg/kg

Serious: 2/3 (67%)

Deaths: 2/3

Dose Escalation Part: 0.6 mg/kg

Serious: 1/3 (33%)

Deaths: 1/3

Dose Escalation Part: 0.9 mg/kg

Serious: 0/3 (0%)

Deaths: 0/3

Dose Escalation Part: 1.2 mg/kg

Serious: 2/3 (67%)

Deaths: 0/3

Dose Escalation Part: 1.5 mg/kg

Serious: 2/3 (67%)

Deaths: 0/3

Dose Escalation Part: 1.8 mg/kg

Serious: 2/3 (67%)

Deaths: 0/3

Dose Escalation Part: 2.0 mg/kg

Serious: 2/3 (67%)

Deaths: 0/3

Dose Escalation Part: 2.2 mg/kg

Serious: 4/6 (67%)

Deaths: 0/6

Dose Expansion Part: Bladder Cancer

Serious: 7/15 (47%)

Deaths: 0/15

Dose Expansion Part: Cervical Cancer

Serious: 26/55 (47%)

Deaths: 2/55

Dose Expansion Part: Endometrial Cancer

Serious: 5/14 (36%)

Deaths: 0/14

Dose Expansion Part: Esophageal Cancer

Serious: 8/15 (53%)

Deaths: 1/15

Dose Expansion Part: Non-Small-Cell Lung Cancer

Serious: 6/15 (40%)

Deaths: 1/15

Dose Expansion Part: Ovarian Cancer

Serious: 13/36 (36%)

Deaths: 2/36

Dose Expansion Part: Prostate Cancer

Serious: 6/18 (33%)

Deaths: 1/18

Serious adverse events (87 terms)

Reaction	System	Dose Escalation Part: 0.3 …	Dose Escalation Part: 0.6 …	Dose Escalation Part: 0.9 …	Dose Escalation Part: 1.2 …	Dose Escalation Part: 1.5 …	Dose Escalation Part: 1.8 …	Dose Escalation Part: 2.0 …	Dose Escalation Part: 2.2 …	Dose Expansion Part: Bladd…	Dose Expansion Part: Cervi…	Dose Expansion Part: Endom…	Dose Expansion Part: Esoph…	Dose Expansion Part: Non-S…	Dose Expansion Part: Ovari…	Dose Expansion Part: Prost…
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vaginal haemorrhage	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Colitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oesophageal perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Subileus	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Ascites	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Lower respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (293 terms — click to expand)

Reaction	System	Dose Escalation Part: 0.3 …	Dose Escalation Part: 0.6 …	Dose Escalation Part: 0.9 …	Dose Escalation Part: 1.2 …	Dose Escalation Part: 1.5 …	Dose Escalation Part: 1.8 …	Dose Escalation Part: 2.0 …	Dose Escalation Part: 2.2 …	Dose Expansion Part: Bladd…	Dose Expansion Part: Cervi…	Dose Expansion Part: Endom…	Dose Expansion Part: Esoph…	Dose Expansion Part: Non-S…	Dose Expansion Part: Ovari…	Dose Expansion Part: Prost…
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Conjunctivitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Neuropathy peripheral	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vaginal haemorrhage	Reproductive system and breast disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Vision blurred	Eye disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Flushing	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Mucosal inflammation	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Vomiting, Abdominal pain, Constipation, Diarrhoea, Dysphagia, Nausea, Urinary tract infection, Malaise.

Data from ClinicalTrials.gov NCT02001623 adverse events section.

Sponsor's own description

The purpose of the trial is to establish the tolerability of HuMax-TF-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):

Antibody-drug conjugates for cancer therapy.
Thomas A, Teicher BA, Hassan R. · · 2016 · cited 436× · PMID 27299281 · DOI 10.1016/s1470-2045(16)30030-4
Tisotumab vedotin in patients with advanced or metastatic solid tumours (InnovaTV 201): a first-in-human, multicentre, phase 1-2 trial.
de Bono JS, Concin N, Hong DS, Thistlethwaite FC, et al · · 2019 · cited 177× · PMID 30745090 · DOI 10.1016/s1470-2045(18)30859-3
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
Stepping forward in antibody-drug conjugate development.
Jin Y, Schladetsch MA, Huang X, Balunas MJ, et al · · 2022 · cited 136× · PMID 34171334 · DOI 10.1016/j.pharmthera.2021.107917
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
Tissue Factor and Cancer: Regulation, Tumor Growth, and Metastasis.
Hisada Y, Mackman N. · · 2019 · cited 132× · PMID 31096306 · DOI 10.1055/s-0039-1687894
A review of the clinical efficacy of FDA-approved antibody‒drug conjugates in human cancers.
Liu K, Li M, Li Y, Li Y, et al · · 2024 · cited 114× · PMID 38519953 · DOI 10.1186/s12943-024-01963-7
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6

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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 NCT02001623 (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 Seagen Inc.
Last refreshed: 29 December 2021

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/NCT02001623.

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

NCT02001623

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 (87 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Ovary Cancer

Other Seagen Inc. trials

Verify against primary sources