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Phase 1/2, Open-label Study of ETX-929, a KRAS Inhibitor in Participants With Advanced Solid Tumors
Sponsor: Ensem Therapeutics
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
Conditions
Interventions
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.
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