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NCT05216432 · ClinicalTrials.gov registry record · Phase 1
First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer
A Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 930
- Enrollment target
- 20
- Study locations
NCT05216432: Recruiting Phase 1 study of Breast Cancer and Metastatic Breast Cancer, sponsored by Relay Therapeutics.
NCT05216432 is a Phase 1 study of Breast Cancer and Metastatic Breast Cancer that is actively recruiting participants, run by Relay Therapeutics. The registered enrollment target is 930 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05216432, a Phase 1 study of Breast Cancer and Metastatic Breast Cancer, is actively recruiting participants, sponsored by Relay Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 930 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalytic subunit alpha (PIK3CA) mutation in blood and/or tumor per local assessment. The study will evaluate RLY-2608 as a single agent for patients with unresectable or metastatic solid tumors. It will also evaluate RLY-2608 in combination RLY-2608 + fulvestrant and in triple combination RLY-2608 + fulvestrant + CDK4/6 inhibitor (palbociclib or ribociclib) or CDK4 inhibitor (PF-07220060) for patients with HR+ HER2- locally advanced or metastatic breast cancer. The RLY-2608 single agent arm, RLY-2608 + fulvestrant combination arm, and triple combination arms will have 2 parts: a dose escalation (Part 1) and a dose expansion (Part 2).
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Ribociclib 400mg
- DRUG Palbociclib 125mg
- DRUG Ribociclib 600mg
- DRUG RLY-2608
Study Locations (20)
New York
- NYU Langone - New York
- Columbia University Herbert Irving Comprehensive Cancer Center - New York
- Memorial Sloan Kettering - New York
Florida
- Florida Cancer Specialists - Orlando
- Boca Raton Clinical Research (BRCR) Global - Plantation
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Texas
- University of Texas Southwestern Medical Center - Dallas
- The University of Texas M.D. Anderson Cancer Center - Houston
Arizona
- The University of Arizona Cancer Center - Tucson
California
- University of California-San Diego - San Diego
Colorado
- HealthONE - Denver
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 930 participants |
| Start Date | 2021-12-08 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
What NCT05216432 shows while recruiting
NCT05216432 is an interventional study that assigns participants to a tested intervention. The registered 930 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (67% lower).
The record links to 7 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Fulvestrant is the first listed.
NCT05216432 names 20 study sites across 15 states, led by New York, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05216432 about?
NCT05216432 is a clinical study titled "First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer". This is an open-label, FIH study designed to evaluate the maximum tolerated dose, recommended Phase 2 dose, safety, tolerability, PK, pharmacodynamics, and preliminary antineoplastic activity of RLY-2608, in advanced solid tumor patients with a Phosphatidylinositol-4,5-bisphosphate-3 kinase, catalyt...
What is the current status of trial NCT05216432?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 930 participants. The study started on 2021-12-08. Estimated completion is 2027-04-30.
What conditions does trial NCT05216432 study?
This clinical trial studies the following conditions: Breast Cancer, Metastatic Breast Cancer, Solid Tumor, Adult, HER2-Negative Breast Cancer, Advanced Breast Cancer.
What interventions are being tested in trial NCT05216432?
The interventions under investigation include: Fulvestrant (DRUG), Ribociclib 400mg (DRUG), Palbociclib 125mg (DRUG), Ribociclib 600mg (DRUG), RLY-2608 (DRUG).
Who is sponsoring clinical trial NCT05216432?
This trial is sponsored by Relay Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05216432 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05216432's enrollment target sits among peer trials
930 133rd of 1224 higher than 1,092 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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