Status:
RECRUITING
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Lead Sponsor:
Incyte Corporation
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
January 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT06179160
Start Date
January 4 2024
End Date
January 1 2027
Last Update
December 18 2025
Active Locations (34)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Stanford University
Palo Alto, California, United States, 94305
3
UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States, 90404
4
Sarah Cannon Research Institue At Healthone
Denver, Colorado, United States, 80218