RECRUITING

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

Conditions

Solid Tumors INCB161734 KRASG12D Mutation pancreatic ductal adenocarcinoma (PDAC)colorectal cancer (CRC)non-small cell lung cancer (NSCLC)

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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

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

Official Title

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

Quick Facts

Study Start:2024-01-04

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06179160

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 Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Principal Investigator

Incyte Medical Monitor

STUDY_DIRECTOR

Incyte Corporation

Study Locations (Sites)

Mayo Clinic Hospital

Phoenix, Arizona, 85054

United States

Stanford University

Palo Alto, California, 94304

United States

UCLA Healthcare Hematology-Oncology

Santa Monica, California, 90404

United States

Sarah Cannon Research Institue At Healthone

Denver, Colorado, 80218

United States

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Florida Cancer Specialists

Sarasota, Florida, 34232

United States

Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

Baltimore, Maryland, 21287

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Mayo Clinic

Rochester, Minnesota, 55905

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Weill Cornell Medicine

New York, New York, 10021

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10022

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 Date2024-01-04

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2024-01-04

Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

INCB161734
KRASG12D Mutation
pancreatic ductal adenocarcinoma (PDAC)
colorectal cancer (CRC)
non-small cell lung cancer (NSCLC)

Additional Relevant MeSH Terms

Solid Tumors