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

About

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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

≥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

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