NCT05759949View on ClinicalTrials.gov

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

41

Participants

Timeline

Start Date

March 29, 2023

Primary Completion Date

March 18, 2025

Study Completion Date

April 11, 2025

Conditions
PIK3CA MutationSolid Tumor, AdultHER2-negative Breast CancerBreast CancerMetastatic Breast CancerAdvanced Breast CancerUnresectable Solid TumorHormone Receptor Positive Tumor
Interventions
DRUG

RLY-5836

RLY-5836 is a mutant-selective, oral PI3Kα inhibitor.

DRUG

Fulvestrant

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.

DRUG

Palbociclib

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.

DRUG

Ribociclib

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.

DRUG

Abemaciclib

Abemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center-Main Campus, New York

32827

Sarah Cannon Research Institute at Florida Cancer Specialists, Orlando

37203

Tennessee Oncology, PLLC, Nashville

46250

Community Cancer Center North, Indianapolis

84112

Huntsman Cancer Institute, University of Utah, Salt Lake City

02114

Massachusetts General Hospital, Boston

08903

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
lead

Relay Therapeutics, Inc.

INDUSTRY