Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

Breast Cancer Metastatic Breast Cancer Solid Tumor, Adult HER2-Negative Breast Cancer Advanced Breast Cancer Unresectable Solid Tumor PIK3CA Mutation

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

FieldValue
Enrollment Target 930 participants
Start Date 2021-12-08
Est. Completion 2027-04-30
Phase Phase 1

Sponsor

Relay Therapeutics

5 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 930 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Relay Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Breast Cancer

All registered trials for this condition

Metastatic Breast Cancer

All registered trials for this condition

Arizona

All trials with a study site in Arizona

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.