Overview
A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Status:
Recruiting
Recruiting
Trial end date:
2027-01-01
2027-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Incyte CorporationTreatments:
Cetuximab
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:
- 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