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RECRUITING
NCT07912593
PHASE1/PHASE2

Phase 1/2, Open-label Study of ETX-929, a KRAS Inhibitor in Participants With Advanced Solid Tumors

Sponsor: Ensem Therapeutics

View on ClinicalTrials.gov

Summary

This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.

Official title: A Phase 1/2, First-in-Human Study of ETX-929, a Pan-KRAS Inhibitor, as Monotherapy and in Combination With Other Anticancer Therapies in Participants With KRAS-Altered Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

320

Start Date

2026-10-22

Completion Date

2029-04-30

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

DRUG

ETX-929 dose escalation

ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule that will be taken once per day in 21-day cycles, to evaluate escalating dose levels.

DRUG

ETX-929 dose escalation in combination with cetuximab

ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule. ETX-929 will be taken in combination with cetuximab in 28-day cycles, to evaluate escalating dose levels. EXT-929 is an oral capsule that will be taken once per day. Cetuximab will be administered intravenously every two weeks.

Locations (1)

NEXT

Fairfax, Virginia, United States