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Study of INCB161734 for Advanced Solid Tumors with KRAS G12D Mutation

This study is testing a new drug called INCB161734, either by itself or combined with other cancer treatments like Cetuximab, Retifanlimab, GEMNabP, or mFOLFIRINOX. It's for people aged 18 or older who have advanced or metastatic (spread) solid tumors with a specific genetic change called a KRAS G12D mutation. You might be able to join if your cancer has progressed on prior treatments or if other treatments aren't suitable. The main goal is to see how safe INCB161734 is and what side effects it might cause. This study plans to enroll about 710 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 710 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events for up to 2 years and 90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06179160

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Recruiting
PHASE1Ages 18+InterventionalTreatment
Incyte Corporation
~710 participants
Updated 2026-07-22 on ClinicalTrials.gov
What's tested:INCB161734CetuximabRetifanlimabGEMNabPmFOLFIRINOXFOLFOX

At a glance

Recruiting sites
34 of 34 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Dose Limiting Toxicities (DLTs)
Measured over Up to 28 days
+2 more outcomes measured

Conditions

Solid Tumors

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Where it's being run

34 sites across 20 states
Belgium3
France3
Italy3
Spain3
California2
New York2
New South Wales2
Victoria2

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

≥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

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

What this trial measures

  • Number of participants with Dose Limiting Toxicities (DLTs)Up to 28 days

    Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.

  • Number of participants with Treatment-emergent Adverse Events (TEAEs)Up to 2 years and 90 days

    Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab.

  • Number of participants with TEAEs leading to dose modification or discontinuationUp to 2 years and 90 days

    Number of participants with TEAEs leading to dose modification or discontinuation.