ACTIVE_NOT_RECRUITING

A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

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Conditions

Solid TumorsINCB186748KRASG12D Mutationpancreatic ductal adenocarcinoma (PDAC)colorectal cancer (CRC)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.

Official Title

A Phase 1, Open-Label, Multicenter Study of INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation

Quick Facts

Study Start:2025-03-27
Study Completion:2027-03-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06818812

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old.
  2. * Locally advanced or metastatic solid tumor with KRAS G12D mutation.
  3. * For Part 1 and Part 2 Combination Group 1: Disease progression on or after prior standard treatment, or intolerance to or ineligibility for standard treatment, or no standard available treatment to improve the disease outcome.
  4. * For Part 2 Combination Groups 2 and 3: No more than 1 prior standard treatment.
  5. * Cohort-specific requirements as follows:
  6. * Parts 1a and 1d: histologically or cytologically confirmed malignant solid tumor of any tissue origin.
  7. * Part 1b
  8. * Disease Group 1: diagnosis of PDAC and at least 1 but no more than 2 prior standard systemic regimens for pancreatic cancer.
  9. * Disease Group 2: diagnosis of CRC.
  10. * Part 1c: Confirmed diagnosis of PDAC or CRC.
  11. * Parts 2a and 2b
  12. * Combination Group 1 (INCB186748 in combination with cetuximab):
  13. * Diagnosis of PDAC or
  14. * Diagnosis of CRC and ∘ Prior treatment in the advanced setting with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan and
  15. * In Part 2a: ≤ 3 prior standard regimens.
  16. * In Part 2b: ≤ 2 prior standard regimens.
  17. * Combination Group 2 (INCB186748 in combination with GEMNabP) and
  18. * Combination Group 3 (INCB186748 in combination with mFOLFIRINOX):
  19. * Diagnosis of PDAC.
  20. * ≤ 1 prior standard systemic regimen for pancreatic cancer.
  21. * Measurable disease according to RECIST v1.1.
  22. * ECOG performance status score of 0 or 1.
  1. * Prior treatment with any KRAS inhibitor.
  2. * Known additional invasive malignancy within 1 year of the first dose of study drug.
  3. * History of organ transplant, including allogeneic stem cell transplantation.
  4. * Significant, uncontrolled medical condition.
  5. * History or presence of an ECG abnormality.
  6. * Inadequate organ function.

Contacts and Locations

Principal Investigator

Incyte Medical Monitor
STUDY_DIRECTOR
Incyte Corporation

Study Locations (Sites)

UCLA Healthcare Hematology-Oncology
Santa Monica, California, 90404
United States
Sarah Cannon Research Institue At Healthone
Denver, Colorado, 80218
United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
United States
Florida Cancer Specialists
Sarasota, Florida, 34232
United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, 21287-7049
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, 19107
United States
Scri Oncology Partners
Nashville, Tennessee, 37203
United States
Md Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Incyte Corporation

  • Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27
Study Completion Date2027-03-27

Study Record Updates

Study Start Date2025-03-27
Study Completion Date2027-03-27

Terms related to this study

Keywords Provided by Researchers

  • INCB186748
  • KRASG12D Mutation
  • pancreatic ductal adenocarcinoma (PDAC)
  • colorectal cancer (CRC)

Additional Relevant MeSH Terms

  • Solid Tumors