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Evaluating INCB161734 for advanced solid tumors with KRAS G12D mutation

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Phase 1 Interventional Incyte Corporation · NCT06179160

This study is testing a new drug called INCB161734, alone and with other cancer treatments, to see if it can help people with advanced solid tumors that have a specific KRAS G12D mutation.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment710 (estimated)
Ages18 Years and up
SexAll
SponsorIncyte Corporation Industry-sponsored
Locations37 sites (Phoenix, Arizona and 36 other locations)
Trial IDNCT06179160 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of INCB161734, both as a standalone treatment and in combination with other anticancer therapies, for patients with advanced or metastatic solid tumors harboring the KRAS G12D mutation. Participants will be enrolled based on specific eligibility criteria, including prior treatment history and tumor type. The study will involve various treatment combinations, including INCB161734 with Cetuximab, Retifanlimab, GEMNabP, and mFOLFIRINOX.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with locally-advanced or metastatic solid tumors that have the KRAS G12D mutation.

Not a fit: Patients without the KRAS G12D mutation or those who have already received multiple lines of treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors associated with the KRAS G12D mutation.

How similar studies have performed: Other studies targeting KRAS mutations have shown promise, indicating that this approach may be viable and beneficial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* ≥18 years old.
* Locally advanced or metastatic solid tumor with KRAS G12D mutation.
* For Part 1a and Part 2 Combination Groups 1, 2, and 7: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, declined available therapies that are known to confer clinical benefit, or no standard available treatment to improve the disease outcome.
* Cohort specific requirements aas defined in the protocol.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

* Prior treatment with any KRAS G12D inhibitor
* Known additional invasive malignancy within 1 year of the first dose of study drug
* History of organ transplant, including allogeneic stem cell transplantation
* Significant, uncontrolled medical condition
* History or presence of an ECG abnormality
* Inadequate organ function

Other protocol-defined Inclusion/Exclusion Criteria may apply

Where this trial is running

Phoenix, Arizona and 36 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsINCB161734KRASG12D Mutationpancreatic ductal adenocarcinomacolorectal cancernon-small cell lung cancer
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.