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

RecruitingPhase 1

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

Who can join

Ages 18 and older · All sexes

Full eligibility 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

About the study

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

What is being tested

Sponsor: Incyte Corporation · Participants: 710 · Started: Jan 4, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06179160

Locations in the U.S.

ArizonaMayo Clinic Hospital, Phoenix
CaliforniaStanford University, Palo Alto
UCLA Healthcare Hematology-Oncology, Santa Monica
ColoradoSarah Cannon Research Institue At Healthone, Denver
FloridaFlorida Cancer Specialists, Sarasota
MarylandSidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore
MassachusettsDana Farber Cancer Institute, Boston
New JerseyHackensack University Medical Center, Hackensack
New YorkMemorial Sloan Kettering Cancer Center, New York
Weill Cornell Medicine, New York
PennsylvaniaJefferson University Hospitals, Philadelphia
TennesseeScri Oncology Partners, Nashville
TexasMd Anderson Cancer Center, Houston

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.