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Antibody-drug conjugate

Tisotumab vedotin (HuMax-TF-ADC) for Bladder Cancer

Phase 1 & 2
Waitlist Available
Led By Johann de Bono, Professor
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (part 2) of cycle 1
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The purpose of the trial is to establish the tolerability of tisotumab vedotin (HuMax-TF-ADC) dosed three times every four weeks (3q4wk) in a mixed population of patients with specified solid tumors.

Eligible Conditions
  • Bladder Cancer
  • Prostate Cancer
  • Endometrial Cancer
  • Cervical Cancer
  • Esophageal Cancer
  • Non-Small Cell Lung Cancer
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (part 2) of cycle 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 to 2 hours post-dose on days 1, 8, 15, +24 hrs 1st infusion, +24 hrs 3rd infusion, +72 hrs 3rd infusion, +168 hrs 3rd infusion (part 1) and 0 to 2 hours post-dose on day 1, and pre-dose days 8 and 15 (part 2) of cycle 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Number of Participants Reporting One or More Common Terminology Criteria for Adverse Events (CTCAE) Grade >=3 Adverse Events
Part 1: Number of Participants Reporting One or More Infusion-related Adverse Events
Part 1: Number of Participants Reporting One or More Treatment-related Adverse Events
+7 more
Secondary study objectives
Part 1 & Part 2: Apparent Volume of Distribution (Vz) for Total HuMax-TF (Conjugated and Non-conjugated)
Part 1 and Part 2: Total Clearance (CL) of Total HuMax-TF (Conjugated and Non-conjugated)
Part 1: AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Tisotumab Vedotin (HuMax-TF-ADC)
+27 more

Side effects data

From 2017 Phase 1 & 2 trial • 33 Patients • NCT02552121
100%
Epistaxis
67%
Nausea
67%
Decreased appetite
67%
Conjunctivitis
67%
Fatigue
33%
Rhinitis
33%
Myalgia
33%
Pyrexia
33%
Dyspepsia
33%
Dry mouth
33%
Tongue blistering
33%
Dizziness
33%
Weight decreased
33%
Symblepharon
33%
Pneumonia
33%
Influenza
33%
Cough
33%
Polyneuropathy
33%
Pain
33%
Anaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: Dose Escalation: Cohort 1 3q4wk 0.9 mg/kg
Part 1: Dose Escalation: Cohort 2 3q4wk 1.2 mg/kg
Part 2 Cohort Expansion: Cohort 3 3q4wk - 1q3w Ovarian
Part 2: Cohort Expansion: Cohort 4 3q4wk - 1q3w Cervical
Part 2 Cohort Expansion: Cohort 5 1q3w Ovarian
Part 2: Cohort Expansion: Cohort 1 3q4wk Ovarian
Part 2: Cohort Expansion: Cohort 2 3q4wk Cervical
Part 2: Cohort Expansion: Cohort 6 1q3w Cervical

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tisotumab vedotin (HuMax-TF-ADC)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tisotumab vedotin
FDA approved

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
74,397 Total Patients Enrolled
GenmabIndustry Sponsor
71 Previous Clinical Trials
14,888 Total Patients Enrolled
Johann de Bono, ProfessorPrincipal InvestigatorThe Institute of Cancer Research & The Royal Marsden NHS Foundation Trust
2 Previous Clinical Trials
1,217 Total Patients Enrolled
~3 spots leftby Nov 2025
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