A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS… (NCT06818812) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
United States30 participantsStarted 2025-03-27
Plain-language summary
The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 performanc…
What they're measuring
1
Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: Up to 28 days
2
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to approximately 12 months and 60 days
3
Number of participants with TEAEs leading to dose modification or discontinuation
Timeframe: Up to approximately 12 months and 60 days