Phase I Study of BAY1436032 in IDH1-mutant Advanced Solid Tumors
Status:
Active, not recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
The primary objective of this study is:
- Determine the safety, tolerability, maximum tolerated dose (MTD) or recommended Phase II
dose (RP2D) of BAY 1436032 in patients with isocitrate dehydrogenase-1 (IDH1)-R132X-mutant
advanced solid tumors.
The secondary objectives of this study are:
- Evaluate the pharmacokinetics (PK) of BAY1436032 in patients with IDH1-R132X-mutant
advanced solid tumors.
- Evaluate the effect of a standard high-fat, high calorie meal on the PK of BAY1436032.
- Assess pharmacodynamic (PD) effects and evidence of clinical efficacy associated with
BAY1436032 administration in patients with IDH1-R132X-mutant advanced solid tumors.