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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Relay Therapeutics, Inc.
Study ID
NCT05759949
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of RLY-5836 in advanced solid tumors in participants harboring a PIK3CA mutation in blood and/or tumor per local assessment. The study consists of 2 parts, a dose escalation (Part 1) and a dose expansion (Part 2).

Key Dates

Start date
Mar 29, 2023
Status verified
May 2025
Primary completion
Mar 18, 2025
Completion
Apr 11, 2025

Study Design

Enrollment
41 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RLY-5836 Single Agent Arm
    RLY-5836 single agent arm for participants with unresectable or metastatic solid tumors
  • Experimental: RLY-5836 + Fulvestrant Arm
    RLY-5836 + fulvestrant combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
  • Experimental: RLY-5836 + Palbociclib + Fulvestrant Arm
    RLY-5836 + palbociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
  • Experimental: RLY-5836 + Ribociclib + Fulvestrant Arm
    RLY-5836 + ribociclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer
  • Experimental: RLY-5836 + Abemaciclib + Fulvestrant Arm
    RLY-5836 + abemaciclib + fulvestrant triple combination arm for participants with HR+, HER2- locally advanced or metastatic breast cancer

Primary Outcome Measure

Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of RLY-5836 [ Time Frame: 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 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Sarah Cannon Research Institute at Florida Cancer SpecialistsOrlandoFlorida32827-
Community Cancer Center NorthIndianapolisIndiana46250-
Massachusetts General HospitalBostonMassachusetts02114-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
Memorial Sloan Kettering Cancer Center-Main CampusNew YorkNew York10065-
Tennessee Oncology, PLLCNashvilleTennessee37203-
Huntsman Cancer Institute, University of UtahSalt Lake CityUtah84112-

Find similar trials in Orlando, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sarah Cannon Research Institute at Florida Cancer Specialists· Orlando, FLCommunity Cancer Center North· Indianapolis, INMassachusetts General Hospital· Boston, MARutgers Cancer Institute of New Jersey· New Brunswick, NJMemorial Sloan Kettering Cancer Center-Main Campus· New York, NYTennessee Oncology, PLLC· Nashville, TN

Related Studies