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Ribociclib 400mg

DRUG3 trials

Sponsors

Relay Therapeutics, Inc., Yale University, Nagoya City University

Conditions

Advanced Breast CancerBreast CancerHER2 Negative Breast CancerHER2-negative Breast CancerMetastatic Breast CancerPIK3CA MutationSolid Tumor, AdultUnresectable Solid Tumor

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
RecruitingNCT05216432
Relay Therapeutics, Inc.Advanced Breast Cancer, Breast Cancer, HER2-negative Breast Cancer +4
Start: 2021-12-08End: 2027-04-30Target: 930Updated: 2025-09-22
Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer
Not yet recruitingNCT07164976
Nagoya City UniversityBreast Cancer
Start: 2025-10-01End: 2030-04-01Target: 86Updated: 2025-09-10

Phase 2

Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
RecruitingNCT06953882
Yale UniversityHER2 Negative Breast Cancer
Start: 2025-07-09End: 2030-09-30Target: 140Updated: 2025-07-14

Related Papers

Abstract PD10-07: Efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patient (pt) subset populations, including pts with PIK3CA-mutant HR+/HER2- advanced breast cancer (BC) pre-treated with fulvestrant or other SERD
Clinical Cancer Research2026-02-17
Abstract PS5-09-06: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-positive, HER2-negative Breast Cancer with a Combination Regimen of Ribociclib and Optimized Endocrine Therapy - SELECT Trial
Clinical Cancer Research2026-02-17
Abstract PS7-01: Efficacy of RLY-2608, a mutant-selective PI3Kα inhibitor in patients with PIK3CA-mutant HR+HER2- advanced breast cancer: ReDiscover trial
Clinical Cancer Research2025-06-13
Updated efficacy of mutant-selective PI3Kα inhibitor RLY-2608 in combination with fulvestrant in patients with <i>PIK3CA</i> -mutant HR+HER2- advanced breast cancer: ReDiscover trial.
Journal of Clinical Oncology2025-05-282 citations
Abstract 5977: Identification and characterization of an allosteric and mutant-selective PI3Kα inhibitor
Cancer Research2025-04-21
First-in-human study of RLY-2608, a pan-mutant and isoform selective PI3Kα inhibitor, as a single agent in patients (pts) with advanced solid tumors and in combination with fulvestrant in pts with advanced breast cancer.
Journal of Clinical Oncology2024-06-016 citations
Abstract PO3-20-03: First-in-human global study of RLY-2608, a pan-mutant and isoform selective PI3Kα inhibitor, as a single agent in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced breast cancer
Cancer Research2024-05-02
Abstract CT017: Pan-mutant and isoform selective PI3Kα inhibitor, RLY-2608, demonstrates selective targeting in a first-in-human study of <i>PIK3CA-</i>mutant solid tumor patients, ReDiscover trial
Cancer Research2023-05-296 citations
Abstract OT3-22-01: First-in-human global multi-center study of RLY-2608, a pan mutant and isoform selective PI3Kα inhibitor, as a single agent in advanced solid tumor patients and in combination with fulvestrant in patients with advanced breast cancer
Cancer Research2023-03-011 citations
First-in-human global multi-center study of RLY-2608, a pan-mutant and isoform-selective PI3Kα inhibitor, as a single agent in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced breast cancer.
Journal of Clinical Oncology2022-06-014 citations