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Taking people in United StatesPhase 1/2

Tests ETX-929, a KRAS inhibitor, in adults with advanced KRAS-altered solid tumors

Tests ETX-929, a KRAS inhibitor, in adults with advanced solid tumors carrying KRAS changes.

Key facts

Who runs it
Ensem Therapeutics
Where
Fairfax, United StatesSee the site
Trial code
Registry title
A KRAS Inhibitor in Participants With Advanced Solid Tumors
Status
Recruiting
Phase
Phase 1/2
People taking part
320 people, planned
Started
22 Oct 2026
Expected to end
30 Apr 2029
Type of study
Interventional, 4 groups
Treatments tested
  • ETX-929 dose escalation
  • ETX-929 dose escalation in combination with cetuximab
Record updated
12 November 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement
  • Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied

Where in United States

  • NEXTFairfax, United StatesContact: Maybelle De La RosaTaking people

About the trial

What the trial wants to find out

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.

The 4 groups in the trial

  • Part A Dose Escalation MonotherapyTreatment being tested

    Part A is a dose escalation monotherapy of ETX-929 in advanced solid tumors with KRAS alterations.

    Treatment: ETX-929 dose escalation

  • Part B Dose Escalation Combination TherapyTreatment being tested

    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.

    Treatment: ETX-929 dose escalation in combination with cetuximab

  • Part C Dose ExpansionTreatment being tested

    Part C will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.

    Treatment: ETX-929 dose escalation

  • Part D Dose Expansion Combination TherapyTreatment being tested

    Part D will evaluate ETX-929 at the recommended Phase 2 dose (RP2D\[s\]) established in Part A.

    Treatment: ETX-929 dose escalation in combination with cetuximab

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests ETX-929, a KRAS inhibitor, in adults with advanced KRAS-altered solid tumorsGenerated from the registry record. The registry title is the official one.
Record updated
12 November 2026