Trials / Completed
CompletedNCT02552121
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
Dose-escalating and Cohort Expansion Safety Trial of Tissue Factor Specific Antibody Drug Conjugate Tisotumab Vedotin (HuMax®-TF-ADC) in Patients With Locally Advanced and/or Metastatic Solid Tumors Known to Express Tissue Factor
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 33 (actual)
- Sponsor
- Seagen Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study is conducted in two parts. In the Dose Escalation portion of the trial, subjects are enrolled into cohorts at increasing dose levels of tisotumab vedotin (HuMax-TF-ADC) in 28 day treatment cycles. The Cohort Expansion portion of the trial will further explore the recommended phase 2 dose of tisotumab vedotin (HuMax-TF-ADC) as determined in Part 1.
Conditions
- Ovary Cancer
- Cervix Cancer
- Endometrium Cancer
- Bladder Cancer
- Prostate Cancer (CRPC)
- Esophagus Cancer
- Lung Cancer (NSCLC)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tisotumab vedotin (HuMax-TF-ADC) |
Timeline
- Start date
- 2015-11-30
- Primary completion
- 2017-12-13
- Completion
- 2017-12-13
- First posted
- 2015-09-16
- Last updated
- 2021-04-08
- Results posted
- 2019-03-12
Locations
16 sites across 5 countries: United States, Belgium, Denmark, Hungary, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02552121. Inclusion in this directory is not an endorsement.