RLY-5836 for Advanced Breast Cancer

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Relay Therapeutics, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called RLY-5836 in patients with advanced cancers that have a PIK3CA mutation. The drug aims to block this mutation to slow down tumor growth. The study will determine how safe and effective the drug is.

Eligibility Criteria

This trial is for adults with advanced breast cancer or other solid tumors that have a PIK3CA mutation. Participants should be in good physical condition (ECOG 0-1), and women must be postmenopausal, treated with GnRH agonists, or otherwise not of childbearing potential. They should have tried standard treatments without success or cannot tolerate them.

Inclusion Criteria

I have HR+ and HER2- advanced breast cancer and cannot undergo surgery to cure it.

I am fully active or can carry out light work.

My condition hasn't improved with standard treatments, or I can't tolerate them.

+4 more

Exclusion Criteria

I have diabetes and take medication, or my blood sugar and HbA1c levels are high.

I have previously been treated with PI3Kα inhibitors.

Participant Groups

RLY-5836 is being tested to find the safest and most effective dose for treating advanced solid tumors with a PIK3CA mutation. The study has two parts: first, finding the maximum tolerated dose (Part 1) and then expanding the trial to more patients at this dose (Part 2).

5Treatment groups

Experimental Treatment

Group I: RLY-5836 Single Agent ArmExperimental Treatment1 Intervention

RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors

Group II: RLY-5836 + Ribociclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group III: RLY-5836 + Palbociclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group IV: RLY-5836 + Fulvestrant ArmExperimental Treatment2 Interventions

RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Group V: RLY-5836 + Abemaciclib + Fulvestrant ArmExperimental Treatment3 Interventions

RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer