Calendario›RLAY›RLY-2608

RLY-2608

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

Ensayo de Relay Therapeutics, Inc. en PIK3CA Mutation · Solid Tumor, Adult · HER2-negative Breast Cancer · Breast Cancer · Metastatic Breast Cancer · Advanced Breast Cancer · Unresectable Solid Tumor (del registro, en inglés).

Más ensayos de: Tumor sólido · Cáncer de mama HER2 negativo · Cáncer de mama · Cáncer de mama metastásico · Cáncer de mama avanzado.

Fase

Fase 1

Estado

Reclutando pacientes

Participantes

930

previstos

Centros

37

Fin del objetivo primario

abr 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en dic 2021.

Qué mide

Determination of maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RLY-2608 as a single agent (Cycle 1 (4-week cycle) of treatment for MTD and at the end of every cycle (4-week cycles) for RP2D until study discontinuation, approximately 24 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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).

Más ensayos de RLAY

Todos los de RLAY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT05216432), actualizada en sep 2025.