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

Description

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

Conditions

Solid Tumors

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Study Overview

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Study Details

Study overview

This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.

A Phase 1, Open-Label, Multicenter Study of INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Phoenix

Mayo Clinic Hospital, Phoenix, Arizona, United States, 85054

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Santa Monica

UCLA Healthcare Hematology-Oncology, Santa Monica, California, United States, 90404

Denver

Sarah Cannon Research Institue At Healthone, Denver, Colorado, United States, 80218

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Sarasota

Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Baltimore

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins, Baltimore, Maryland, United States, 21287

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥18 years old
  • * Locally-advanced or metastatic solid tumor with KRAS G12D mutation
  • * For Part 1 and Part 2 Combination Groups 1 and 2: Disease progression on prior standard treatment, intolerance to or ineligibility for standard treatment, or no available standard treatment to improve the disease outcome
  • * For Part 2 Combination Groups 3 and 4: No more than 1 prior standard treatment
  • * Cohort specific requirements as follows:
  • * Parts 1A and 1D: Histologically or cytologically confirmed malignant solid tumor of any tissue origin
  • * Part 1B
  • * Disease group 1: diagnosis of PDAC and ≤ 2 prior standard systemic regimens for pancreatic cancer
  • * 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 or 3
  • * Part 1c: Confirmed diagnosis of PDAC, CRC, or NSCLC
  • * Parts 2A and 2B
  • * Combination 1: Diagnosis of PDAC or Diagnosis of CRC and
  • * Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
  • * In Part 2a: ≤ 3 prior standard regimens
  • * In Part 2b: ≤ 2 prior standard regimens
  • * Combination 2: Diagnoses of PDAC, CRC or NSCLC
  • * Combination Group 3 (INCB161734 in combination with GEMNabP) and Combination Group 4 (INCB161734 in combination with mFOLFIRINOX):
  • * Diagnosis of PDAC
  • * ≤ 1 prior standard systemic regimen for pancreatic cancer
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2027-01-01