Ribociclib 600mg

DRUG3 trials

Sponsors

Relay Therapeutics, Inc., American Society of Clinical Oncology, Nagoya City University

Conditions

Advanced Breast CancerBreast 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 3

The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

RecruitingNCT06377852

American Society of Clinical OncologyMetastatic Breast Cancer

Start: 2024-10-29End: 2028-09-01Target: 500Updated: 2026-03-18

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 PS5-07-08: CDK4/6 inhibitor (CDK4/6i) dosing knowledge (CDK) study: A pragmatic randomized trial of indicated vs. titrated CDK4/6i dosing in older adults with HR+/HER2- metastatic breast cancer (MBC)

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