Overview

A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Status:
Recruiting
Trial end date:
2027-01-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Corporation
Treatments:
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