GEN1046 Safety Trial in Patients With Malignant Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 192
Summary
- Conditions
- Cervical Cancer
- Endometrial Carcinoma
- Non -Small Cell Lung Cancer
- Solid Tumors
- Squamous Cell Carcinoma of the Head and Neck
- Triple -Negative Breast Cancer
- Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Sequential AssignmentIntervention Model Description: The starting dose is administered as a flat dose. Dose escalation steps are based on safety dataMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The trial is an open-label, multi-center safety trial of GEN1046. 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.
The trial is an open-label, multi-center safety trial of GEN1046. 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.
Tracking Information
- NCT #
- NCT03917381
- Collaborators
- BioNTech SE
- Investigators
- Not Provided
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