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RecruitingPhase 1NCT06179160
Official study title

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

Study summary

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedINCB161734 and Cetuximab

Plus 6 other study approaches.

Who it may be forKRAS · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jul 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?34 U.S. locations

Locations may change over time.

Who runs it?Incyte Corporation

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Incyte Corporation
Interventions being studied
Drug: INCB161734; Drug: Cetuximab; Drug: Retifanlimab; Drug: GEMNabP; Drug: mFOLFIRINOX; Drug: FOLFOX; Drug: FOLFIRI; Drug: INCA33890
02
Explore related studies

How this study is categorized

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

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
  • ≥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.
Reasons someone may not be able to joinExclusion 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/

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

  • Mayo Clinic HospitalPhoenix, Arizona
  • Stanford UniversityPalo Alto, California
  • UCLA Healthcare Hematology-OncologySanta Monica, California
  • Sarah Cannon Research Institue At HealthoneDenver, Colorado
  • Florida Cancer SpecialistsSarasota, Florida
  • Sidney Kimmel Comprehensive Cancer Center At Johns HopkinsBaltimore, Maryland
  • Dana Farber Cancer InstituteBoston, Massachusetts
  • Hackensack University Medical CenterHackensack, New Jersey
  • Weill Cornell MedicineNew York, New York
  • Memorial Sloan Kettering Cancer CenterNew York, New York
  • Jefferson University HospitalsPhiladelphia, Pennsylvania
  • Scri Oncology PartnersNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jul 22, 2026. Always confirm current availability with the study team.

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