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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 developed by Relay Therapeutics, Inc. for cancers that carry a PIK3CA mutation. It is being studied in advanced breast cancer and other solid tumors, including HER2-negative, hormone receptor positive, metastatic, and unresectable disease. It is a Phase 1 clinical-stage asset, not an approved medicine.
RLY-5836 targets PI3K, a kinase enzyme. It is a small molecule designed to act on this kinase in tumors that carry a PIK3CA mutation, which is the biomarker used to select patients for its clinical study. Targeting PI3K is intended to interfere with signaling that drives tumor growth in these mutation-defined cancers.
Relay Therapeutics, Inc. is developing RLY-5836. The company trades on the Nasdaq under the ticker RLAY. Relay Therapeutics is the sponsor of the first-in-human clinical study evaluating the compound in patients with PIK3CA-mutant advanced breast cancer and other solid tumors.
RLY-5836 is in Phase 1 development. It is an investigational drug and has not been approved by the FDA. Its single clinical study, a first-in-human trial, has been completed, and the program remains at the early clinical stage of development for PIK3CA-mutant solid tumors and breast cancer.
RLY-5836 has been evaluated in one clinical trial, NCT05759949, titled a first-in-human study of RLY-5836 in advanced breast cancer and other solid tumors. The Phase 1 trial enrolled 41 patients in the United States, included adults 18 years and older of any sex, and has been completed.
RLY-5836 is being studied for PIK3CA-mutant cancers, including advanced and metastatic breast cancer, HER2-negative and hormone receptor positive breast cancer, and unresectable solid tumors. Patient selection in its trial was biomarker-based, meaning enrollment focused on tumors carrying a PIK3CA mutation. It is investigational and not approved for any use.