Trials / Completed
CompletedNCT02001623
Tisotumab Vedotin (HuMax®-TF-ADC) Safety Study in Patients With Solid Tumors
First-in-human, Dose-escalating Safety Study 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
- 195 (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 HuMax-TF-ADC in a mixed population of patients with specified solid tumors.
Detailed description
The study is conducted in two parts. The dose escalation portion of the trial subjects are enrolled into cohorts at increasing dose levels of HuMax-TF-ADC in 21 day treatment cycles. In the Cohort Expansion part of the trial, will further explore the recommended phase 2 dose of 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)
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tisotumab Vedotin (HuMax-TF-ADC) |
Timeline
- Start date
- 2013-11-30
- Primary completion
- 2019-05-02
- Completion
- 2019-05-02
- First posted
- 2013-12-05
- Last updated
- 2021-12-29
- Results posted
- 2021-12-29
Locations
29 sites across 5 countries: United States, Belgium, Denmark, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02001623. Inclusion in this directory is not an endorsement.