drugset / Trial / NCT03673787
A Trial of Ipatasertib in Combination With Atezolizumab
Phase 1/2
Active not recruiting
87 enrolled
Institute of Cancer Research, United Kingdom
Hoffmann-La Roche · collab
Non-randomizedParallel-groupOpen-labelHealth-services research
Summary
This is a single centre, proof-of-concept phase I trial of atezolizumab in combination with ipatasertib. There are two parts to this study, the dose escalation phase (Part A) and the dose expansion phase (Part B). Part A, will determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). This will be followed by the Part B dose expansion phase to further characterise the safety and tolerability and to assess the pharmacodynamic activity of the combination.
Timeline
- Start
- 2018-08-13
- Primary completion
- 2026-03
- Completion
- 2026-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Ipatasertib | Small molecule | 100 mg | Oral |
| Subject | Ipatasertib | Small molecule | 200 mg | Oral |