Trials / Terminated
TerminatedNCT03576131
GEN1029 (HexaBody®-DR5/DR5) Safety Trial in Patients With Malignant Solid Tumors
First-in-human, Open-label, Dose-escalation Trial With Expansion Cohorts to Evaluate Safety of GEN1029 in Patients With Malignant Solid Tumors
- Status
- Terminated
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Genmab · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the trial is to evaluate the safety of GEN1029 (HexaBody®-DR5/DR5) in a mixed population of patients with specified solid tumors
Detailed description
The trial is an open-label, multi-center first-in-human trial of GEN1029 (HexaBody®-DR5/DR5). The trial consists of two parts a dose escalation part (phase 1, first-in-human (FIH) and an expansion part (phase 2a). The expansion part of the trial will be initiated once the Recommended Phase 2 Dose (RP2D) has been determined.
Conditions
- Colorectal Cancer
- Non-small Cell Lung Cancer
- Triple Negative Breast Cancer
- Renal Cell Carcinoma
- Gastric Cancer
- Pancreatic Cancer
- Urothelial Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | GEN1029 (HexaBody®-DR5/DR5) | GEN1029 will be administered intravenously. The dose levels will be determined by the starting dose and the escalation steps taken in the trial. |
Timeline
- Start date
- 2018-04-30
- Primary completion
- 2021-10-12
- Completion
- 2021-10-12
- First posted
- 2018-07-03
- Last updated
- 2023-08-01
- Results posted
- 2022-12-12
Locations
6 sites across 3 countries: United States, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03576131. Inclusion in this directory is not an endorsement.