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

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Brief Summary

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

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

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Study Stats
Protocol No.
24-5111
Category
Adolescent & Young Adults (AYA)
Colorectal Cancer
Lung Cancer
Pancreatic Cancer
Contact
LISA-MARIA YONEMOTO
Location
  • UCLA Santa Monica
For Providers
NCT No.
NCT06179160
For detailed technical eligibility, visit ClinicalTrials.gov.