Trials / Completed
CompletedNCT04937153
GEN1046 Safety and PK in Subjects With Advanced Solid Malignancies
Open-label, Dose-escalation Trial to Evaluate the Safety and Pharmacokinetics of GEN1046 in Japanese Subjects With Advanced Solid Malignancies
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Genmab · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Acasunlimab | Acasunlimab will be administered intravenously (IV) once every 21 days. |
| BIOLOGICAL | Pembrolizumab | Pembrolizumab will be administered IV once every 21 days. |
Timeline
- Start date
- 2021-06-15
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2021-06-23
- Last updated
- 2025-07-16
Locations
2 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04937153. Inclusion in this directory is not an endorsement.