About this trial
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Eligibility criteria
Qualifiers
≥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.
Disqualifiers
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
Trial design
Treatments tested in this trial
- INCB161734
- Cetuximab
- Retifanlimab
- GEMNabP
- mFOLFIRINOX
- FOLFOX
- FOLFIRI
- INCA33890
Treatment groups
6
Treatment groupsSee each treatment group below.