drugset / Trial / NCT05759949
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).
Timeline
- Start
- 2023-03-29
- Primary completion
- 2025-03-18
- Completion
- 2025-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 150 mg | Oral |
| Subject | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Subject | Palbociclib | Small molecule | 125 mg | Oral |
| Subject | RLY-5836 | Unknown | — | Oral |
| Subject | Ribociclib | Small molecule | 600 mg | Oral |