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

Completed · Phase 1

Conditions studied: PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Unresectable Solid Tumor, Hormone Receptor Positive Tumor

In brief

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 facts

Study ID

NCT05759949

Run by

Relay Therapeutics, Inc.

People needed

41

Starts

2023-03-29

Expected to finish

2025-04-11

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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, or participant has declined standard therapy.
• A histologically or cytologically confirmed diagnosis of unresectable or metastatic solid tumor
• Combination arms key inclusion criteria
• 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.

You may not qualify if…

• 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%.

Where it is running

• 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

Full record on ClinicalTrials.gov

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