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

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

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

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