ETX-929 for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors (like colorectal, lung, colon, pancreatic, endometrial, ovarian cancers) that have a KRAS mutation. Participants should have already tried standard treatments or have no other options.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- ETX-929
Trial Overview
The study tests ETX-929, a new drug targeting KRAS mutations. Some participants get only ETX-929 at different doses; others get it combined with cetuximab. The main goals are to check safety and how well the drugs work.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Part D will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.
Part C will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.
Part B is a dose escalation combination therapy in advanced solid tumors with KRAS alterations. The study treatment will be ETX-929, a pan-KRAS inhibitor, in combination with cetuximab at a fixed dose.
Part A is a dose escalation monotherapy of ETX-929 in advanced solid tumors with KRAS alterations.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ensem Therapeutics
Lead Sponsor
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