Trials / Completed
CompletedNCT02988817
Enapotamab Vedotin (HuMax-AXL-ADC) Safety Study in Patients With Solid Tumors
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of Axl-specific Antibody-drug Conjugate (Enapotamab Vedotin, HuMax®-AXL-ADC) in Patients With Solid Tumors
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 306 (actual)
- Sponsor
- Genmab · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
The trial consists of two parts; a dose escalation part (phase I, first in-human (FIH)) and an expansion part (phase IIa). The dose escalation part has 2 dosing schedules: 1 dose every 3 weeks (1Q3W) dose regimen, and 3 doses every 4 weeks (3Q4W) dosing regimen. The Expansion part of the trial will further explore the recommended phase 2 dose and dosing regimens of HuMax-AXL-ADC as determined in dose escalation part.
Conditions
- Ovarian Cancer
- Cervical Cancer
- Endometrial Cancer
- Non Small Cell Lung Cancer (NSCLC)
- Thyroid Cancer
- Melanoma
- Sarcoma
- Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Enapotamab vedotin (HuMax-AXL-ADC) | Enapotamab vedotin (HuMax-AXL-ADC) will be administered intravenously. |
Timeline
- Start date
- 2016-11-23
- Primary completion
- 2021-11-12
- Completion
- 2021-11-12
- First posted
- 2016-12-09
- Last updated
- 2023-08-01
- Results posted
- 2023-01-05
Locations
41 sites across 6 countries: United States, Belgium, Denmark, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02988817. Inclusion in this directory is not an endorsement.