Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

233

Participants

Timeline

Start Date

June 10, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 30, 2027

Conditions
Advanced Solid TumorsAdvanced Breast Cancer
Interventions
DRUG

ETX-636 dose escalation

ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet that will be taken once per day in 28-day cycles, to evaluate escalating dose levels.

DRUG

ETX-636 dose escalation in combination with fulvestrant

ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to evaluate escalating dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.

DRUG

ETX-636 dose expansion in combination with fulvestrant

ETX-636 is a pan-mutant-selective PI3Kα Inhibitor and degrader in the form of an oral tablet. ETX-636 will be taken in combination with fulvestrant in 28-day cycles, to expand selected dose levels. EXT-636 is an oral tablet that will be taken once per day. Fulvestrant will be administered as an injection 2 weeks apart in the first 28 days, followed by monthly injections.

Trial Locations (6)

22031

RECRUITING

NEXT, Fairfax

28078

RECRUITING

Carolina BioOncology Institute, Huntersville

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

78229

RECRUITING

START, San Antonio

92663

RECRUITING

Hoag Memorial Hospital Presbyterian, Newport Beach

94158

RECRUITING

UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Ensem Therapeutics

INDUSTRY