KRAS Inhibitor ETX-929 in advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1/2, open-label study evaluating ETX-929 in participants with KRAS-mutant advanced solid tumors. Part A tests escalating doses of ETX-929 as a standalone therapy; Part B tests ETX-929 with a fixed dose of cetuximab; Parts C and D expand enrollment at the recommended doses for monotherapy and combination. Each participant undergoes a 28-day screening before starting treatment, with ongoing safety, pharmacokinetic, pharmacodynamic, and preliminary efficacy assessments. Eligible cancers include metastatic colorectal cancer, pancreatic ductal adenocarcinoma, non-squamous non-small cell lung cancer, endometrial adenocarcinoma, and ovarian adenocarcinoma.

Why it matters

Who can join: the full rules

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.

Where it's running

• Next
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Lori Cykowski
• Email: lori.cykowski@Ensemtx.com
• Phone: 1-617-383-4993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.