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

PHASE1RecruitingINTERVENTIONAL
Enrollment

930

Participants

Timeline

Start Date

December 8, 2021

Primary Completion Date

April 30, 2027

Study Completion Date

April 30, 2027

Conditions
PIK3CA MutationSolid Tumor, AdultHER2-negative Breast CancerBreast CancerMetastatic Breast CancerAdvanced Breast CancerUnresectable Solid Tumor
Interventions
DRUG

RLY-2608

RLY-2608 is a mutant-selective, oral PI3Kα inhibitor.

DRUG

Fulvestrant

500 mg fulvestrant is administered intramuscularly on Cycle 1 Day 1, Day 15, and Day 1 of each subsequent cycle (where a cycle is 28 days).

DRUG

Palbociclib 125mg

125mg palbociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.

DRUG

Ribociclib 400mg

400mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.

DRUG

Ribociclib 600mg

600mg ribociclib is taken orally once daily for 28-day cycles that include 21 days of treatment followed by 7 days off treatment.

DRUG

PF-07220060 100mg

PF-07220060 100 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle.

DRUG

PF-07220060 300 mg

PF-07220060 300 mg is taken orally twice daily at the same time with RLY-2608 during each 28-day cycle.

Trial Locations (37)

2019

RECRUITING

St Vincents Hospital, Sydney

3000

RECRUITING

Peter MacCallum Cancer Center, Melbourne

3004

RECRUITING

The Alfred Hospital, Melbourne

10016

RECRUITING

NYU Langone, New York

10032

RECRUITING

Columbia University Herbert Irving Comprehensive Cancer Center, New York

10065

RECRUITING

Memorial Sloan Kettering, New York

20141

RECRUITING

Istituto Europeo di Oncologia IRCCS, Milan

22031

RECRUITING

Inova Schar Cancer Center, Fairfax

22301

RECRUITING

NEXT Virginia, Fairfax

28040

RECRUITING

START Madrid - Hospital Fundacion Jimenez Diaz, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

32827

RECRUITING

Florida Cancer Specialists, Orlando

33076

RECRUITING

Institute Bergonié, Bordeaux

33322

WITHDRAWN

Boca Raton Clinical Research (BRCR) Global, Plantation

37203

RECRUITING

Tennessee Oncology, Nashville

46009

RECRUITING

Instituto Valenciano de Oncologia, Valencia

46250

RECRUITING

Community Health Network, Indianapolis

48109

RECRUITING

University of Michigan, Ann Arbor

53792

RECRUITING

UW Carbone Cancer Center, Madison

60637

RECRUITING

University of Chicago Medical Center, Chicago

63110

RECRUITING

Washington University School of Medicine St. Louis, St Louis

69008

RECRUITING

Centre Léon Bérard, Lyon

75235

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

The University of Texas M.D. Anderson Cancer Center, Houston

80218

RECRUITING

HealthONE, Denver

84112

RECRUITING

University of Utah- Huntsman Cancer Center, Salt Lake City

85724

RECRUITING

The University of Arizona Cancer Center, Tucson

89502

RECRUITING

Renown Regional Medical Center, Reno

90293

RECRUITING

University of California-San Diego, San Diego

94805

RECRUITING

Gustave Roussy, Villejuif

06510

RECRUITING

Yale University, New Haven

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

08901

RECRUITING

Rutgers University, New Brunswick

08035

RECRUITING

Vall d'Hebron Instituto de Oncologia, Barcelona

08023

RECRUITING

START Barcelona, Barcelona

08916

RECRUITING

Institut Catala D'Oncologia - Badalona (ICO Badalona), Barcelona

All Listed Sponsors
lead

Relay Therapeutics, Inc.

INDUSTRY