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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
NCT05216432 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05216432
The ClinicalTrials.gov registry entry for NCT05216432 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 930 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Relay Therapeutics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05216432 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New York, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05216432?
This trial is sponsored by Relay Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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