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