A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
About the study
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- ≥18 years old
- Locally-advanced or metastatic solid tumor with KRAS G12D mutation
- Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
- Cohort specific requirements as follows:
- Part 1A: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
- Part 1B
- Disease group 1: diagnosis of PDAC
- Disease group 2: diagnosis of CRC
- Disease group 3: diagnosis of NSCLC
- Disease group 4: diagnosis of other advanced solid tumor and not part of Disease groups 1, 2 and 3
- Parts 2A and 2B
- Combination 1: Diagnosis of CRC or CRC
- Combination 2: Diagnoses of PDAC, CRC or NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
EXCLUSION CRITERIA
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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
Solid Tumors
Age
18+
Phase
PHASE1
Participants Needed
322
Est. Completion Date
Jan 1, 2027
Treatment Type
INTERVENTIONAL
Sponsor
Incyte Corporation
ClinicalTrials.gov NCT Identifier
NCT06179160
Study Number
INCB 161734-101
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