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A KRAS Inhibitor in Participants With Advanced Solid Tumors
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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy. * Tumor harboring a KRAS mutation. * An ECOG performance status score of 0 or 1. * Adequate organ function. Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied. * Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement. * Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days prior to start of treatment. * Has toxicities from previous anticancer therapies that have not resolved to baseline levels with the exception of alopecia and peripheral neuropathy. * Has had radiotherapy outside the target tumor lesions within 14 days prior to start of treatment.
About the study
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.
What is being tested
- ETX-929 dose escalation (drug)
- ETX-929 dose escalation in combination with cetuximab (drug)
Sponsor: Ensem Therapeutics · Participants: 320 · Started: Oct 22, 2026
Contact the study team
- Lori Cykowski · Phone: 1-617-383-4993
Official record on ClinicalTrials.gov — NCT07912593
Locations in the U.S.
| Virginia | NEXT, Fairfax |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.