First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
41actual
Sites
7
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-03-29 | actual | When the study began enrolling |
| Primary completion | 2025-03-18 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-11 | actual | The whole study's end, after follow-up |
| First posted | 2023-03-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- PIK3CA Mutation
- Solid Tumor, Adult
- HER2-negative Breast Cancer
- Breast Cancer
- Metastatic Breast Cancer
- Advanced Breast Cancer
- Unresectable Solid Tumor
- Hormone Receptor Positive Tumor
Interventions
- Drug: RLY-5836
- Drug: Fulvestrant — also filed as Faslodex
- Drug: Palbociclib — also filed as Ibrance
- Drug: Ribociclib — also filed as Kisqali
- Drug: Abemaciclib — also filed as Verzenio
Primary outcomes
what the primary-completion date above is the date OFMaximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836
measured Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months
Number of participants with any dose-limiting toxicity (DLT)
measured Cycle 1, up to 28 days.
Number of participants with adverse events (AEs)
measured Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of participants with serious adverse events (SAEs)
measured Every cycle (4-week cycles) until study discontinuation, approximately 24 months
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