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First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A First-in-Human Study of PI3Kα Inhibitor, RLY-5836, in Combination With Targeted and Endocrine Therapies in Participants With Advanced Breast Cancer and as a Single Agent in Advanced Solid Tumors

NCT05759949•Relay Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•Disease that is refractory to standard therapy, intolerant to standard therapy, or participant has declined standard therapy.
•A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
•Males, postmenopausal females, or pre-/perimenopausal females previously treated with gonadotropin-releasing GnRH agonist at least 4 weeks prior to start of study drug with histologically or cytologically confirmed diagnosis of HR+, HER2- unresectable or metastatic breast cancer that is not amenable to curative therapy.
•Had previous treatment for advanced or metastatic breast cancer with antiestrogen therapy including, but not limited to, selective estrogen receptor degraders (e.g., fulvestrant), selective estrogen receptor modulators (e.g., tamoxifen), and aromatase inhibitors (AI) (letrozole, anastrozole, exemestane)
•Part 1: Prior PI3Kα inhibitor treatment is allowed if taken for \< 14 days and not discontinued due to disease progression, hypersensitivity, or ≥ Grade 3 TEAEs.

Exclusion Criteria

•Part 2: Prior treatment with PI3Kα inhibitors.
•Type 1 or Type 2 diabetes requiring antihyperglycemic medication, or fasting plasma glucose ≥140 mg/dL and glycosylated hemoglobin (HbA1c) ≥7.0%.

Locations (7)

Sarah Cannon Research Institute at Florida Cancer Specialists

Orlando, Florida, United States

Community Cancer Center North

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Memorial Sloan Kettering Cancer Center-Main Campus

New York, New York, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

March 29, 2023

Primary Completion Date

March 18, 2025

Completion Date

April 11, 2025

Last Updated

May 16, 2025

Enrollment

ACTUAL participants

Conditions

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

Interventions

RLY-5836

DRUG

Fulvestrant

DRUG

Palbociclib

DRUG

Ribociclib

DRUG

Abemaciclib

DRUG

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

NCT07483307

Breast CancerHER2-negative Breast Cancer+2 more

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RECRUITINGPHASE1

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

Prospective Cohort With Clinic-biologic Database of Patients Treated by Immunotherapy

Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer

The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)