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Active Not Recruiting
NCT06818812
A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Conditions: Solid Tumors
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 30
Sponsor: Incyte Corporation
Location: UCLA Healthcare Hematology-Oncology Santa Monica California
Summary
The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.
Eligibility Criteria
Inclusion Criteria:
* ≥18 years old.
* Locally advanced or metastatic solid tumor with KRAS G12D mutation.
* 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.
* For Part 2 Combination Groups 2 and 3: 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 at least 1 but no more than 2 prior standard systemic regimens for pancreatic cancer.
* Disease Group 2: diagnosis of CRC.
* Part 1c: Confirmed diagnosis of PDAC or CRC.
* Parts 2a and 2b
* Combination Group 1 (INCB186748 in combination with cetuximab):
* 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 Group 2 (INCB186748 in combination with GEMNabP) and
* Combination Group 3 (INCB186748 in combination with mFOLFIRINOX):
* Diagnosis of PDAC.
* ≤ 1 prior standard systemic regimen for pancreatic cancer.
* Measurable disease according to RECIST v1.1.
* ECOG performance status score of 0 or 1.
Exclusion Criteria:
* Prior treatment with any KRAS 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.
Source: ClinicalTrials.gov (NCT06818812). StuddyBuddy aggregates publicly available trial information.
