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

RECRUITINGPhase 1Sponsored by Incyte Corporation
Actively Recruiting
PhasePhase 1
SponsorIncyte Corporation
Started2024-01-04
Est. completion2027-01-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations16 sites
View on ClinicalTrials.gov →

NCT06179160

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

CancerLung CancerSolid Tumors

Interventions8

CetuximabFOLFIRIFOLFOXGEMNabPINCA33890INCB161734RetifanlimabmFOLFIRINOX

Locations16 sites

Mayo Clinic Hospital
Phoenix, Arizona, 85054
Stanford University
Palo Alto, California, 94305
UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404
Sarah Cannon Research Institue At Healthone
Denver, Colorado, 80218
Mayo Clinic Florida
Jacksonville, Florida, 32224

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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