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RLY-5836

Phase 1

PIK3CA Mutation | Small molecule | Oncology |Relay Therapeutics, Inc.|Last Updated: May 16, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05759949First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid TumorsPHASE1 COMPLETED 41 — — Mar 29, 2023Apr 11, 2025May 16, 20257 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836
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)
Cycle 1, up to 28 days.
Number of participants with adverse events (AEs)
Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Number of participants with serious adverse events (SAEs)
Every cycle (4-week cycles) until study discontinuation, approximately 24 months
Secondary Endpoints
PIK3CA genotype in blood and tumor tissue by next generation nucleic acid sequencing
Every cycle (4-week cycles) through Cycle 3 and every other cycle thereafter until study discontinuation, approximately 24 months
PK of RLY-5836: area under the concentration-time curve (AUC)
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
PK of RLY-5836: maximum plasma concentration (Cmax)
Approximately every 2 weeks in Cycle 1 (4-week cycle) and every cycle through end of treatment (4-week cycles), approximately 24 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RLY-5836 Single Agent ArmEXPERIMENTALRLY-5836 single agent arm for participants with unresectable or metastatic solid tumors
RLY-5836 + Fulvestrant ArmEXPERIMENTALRLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836 + Palbociclib + Fulvestrant ArmEXPERIMENTALRLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836 + Ribociclib + Fulvestrant ArmEXPERIMENTALRLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
RLY-5836 + Abemaciclib + Fulvestrant ArmEXPERIMENTALRLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
Interventions
NameTypeDescription
RLY-5836DRUGRLY-5836 is a mutant-selective, oral PI3Kα inhibitor.
FulvestrantDRUGFulvestrant (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.
PalbociclibDRUGPalbociclib 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.
RibociclibDRUGRibociclib 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.
AbemaciclibDRUGAbemaciclib 150 mg BID will be taken orally in combination with RLY-5836 and fulvestrant for 28-day cycles.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

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,...

Countries:United States
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