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
Incyte Corporation
710 participants
Jan 4, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- ≥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 Criteria6
- 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
Interventions
INCB161734 will be administered at protocol defined dose.
Cetuximab will be administered at protocol defined dose.
Retifanlimab will be administered at protocol defined dose.
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOX will be administered at protocol defined dose.
FOLFOX will be administered at protocol defined dose.
FOLFIRI will be administered at protocol defined dose.
INCA33890 will be administered at protocol defined dose.
Locations(34)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06179160