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RecruitingPhase 1 / Phase 2NCT07912593
Official study title

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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedETX-929 dose escalation and ETX-929 dose escalation in combination with cetuximab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 3, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Ensem Therapeutics

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1 / Phase 2
Sponsor
Ensem Therapeutics
Interventions being studied
Drug: ETX-929 dose escalation; Drug: ETX-929 dose escalation in combination with cetuximab
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Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Metastatic or stage IV→
Biomarkers
KRAS→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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.
Reasons someone may not be able to joinExclusion 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • NEXTFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 3, 2026. Always confirm current availability with the study team.

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