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RLY-5836 · 1 trial · 8 indications
| Arm | Type | Description |
|---|---|---|
| RLY-5836 Single Agent Arm | EXPERIMENTAL | RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors |
| RLY-5836 + Fulvestrant Arm | EXPERIMENTAL | RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Palbociclib + Fulvestrant Arm | EXPERIMENTAL | RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Ribociclib + Fulvestrant Arm | EXPERIMENTAL | RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| RLY-5836 + Abemaciclib + Fulvestrant Arm | EXPERIMENTAL | RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer |
| Name | Type | Description |
|---|---|---|
| RLY-5836 | DRUG | RLY-5836 is a mutant-selective, oral PI3Kα inhibitor. |
| Fulvestrant | DRUG | Fulvestrant (500 mg) is administered IM into the buttocks (gluteal area) slowly (1 to 2 minutes per injection) as 2×5 mL injections, 1 in each buttock, on Cycle 1 Day 1, Cycle 1 Day 15, and Day 1 of each subsequent cycle. |
| Palbociclib | DRUG | Palbociclib 125 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| Ribociclib | DRUG | Ribociclib 600 mg once daily is taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles that include 21 days of treatment followed by 7 days off treatment. |
| Abemaciclib | DRUG | Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles. |
Inclusion Criteria: Patient has ECOG performance status of 0-1 One or more documented primary oncogenic PIK3CA mutation(s) in blood and/or tumor per local assessment RLY-5836 single agent arm key inclusion criteria * Disease that is refractory to standard therapy, intolerant to standard therapy,...
RLY-5836 is an investigational small molecule being developed for the treatment of cancers with PIK3CA mutations, including advanced breast cancer and other solid tumors. It is being studied in patients with HER2-negative, hormone receptor positive, metastatic or advanced breast cancer, as well as unresectable solid tumors.
RLY-5836 targets cancers that harbor PIK3CA mutations. It is designed to act on tumors with this specific genetic alteration, which is common in certain types of breast cancer and other solid tumors. The drug is being evaluated for its potential to treat these mutation-driven cancers.
RLY-5836 is being developed by Relay Therapeutics, Inc., a biopharmaceutical company. Relay Therapeutics is conducting clinical research on this investigational drug for the treatment of PIK3CA-mutated cancers, including advanced breast cancer and other solid tumors.
RLY-5836 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy in patients with PIK3CA-mutated advanced breast cancer and other solid tumors.
RLY-5836 has been studied in a Phase 1 first-in-human clinical trial, identified as NCT05759949. This trial, titled 'First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors,' enrolled 41 participants in the United States and has been completed.
RLY-5836 is the primary name for this investigational drug. No alternative names have been reported for this compound. It is being developed by Relay Therapeutics under this designation for the treatment of PIK3CA-mutated cancers.