A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Step 1 (Dose escalation [Cohorts A and B]) primary objective : In V1/V1 homozygous and V1/V2 heterozygous patients with advanced solid tumors, Dose-Limiting Toxicities (DLTs), Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of BI 765063, as monotherapy (Cohort A) and in combination with BI 754091 (Cohort B). Step 2 (Expansion Cohorts [Cohorts C]) primary objective : In V1/V1 homozygous patients with selected advanced solid tumors, DLT-like events and RP2D confirmation of BI 765063 as monotherapy (Cohort C1) and in combination with BI 754091 (Cohort C2) . Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT03990233
- Collaborators
- Boehringer Ingelheim
- Investigators
- Not Provided
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