A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
NCT ID: NCT06818812
Last Updated: 2025-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-03-27
2027-03-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1a: Dose Escalation monotherapy
INCB186748 at the protocol-defined dose strength based on cohort assignment.
INCB186748
INCB186748 will be administered at protocol defined dose.
Part 1b: Dose Expansion monotherapy
INCB186748 at the protocol-defined dose strength based on cohort assignment.
INCB186748
INCB186748 will be administered at protocol defined dose.
Part 1c: Pharmacodynamic cohort
INCB186748 at the protocol-defined dose strength based on cohort assignment.
INCB186748
INCB186748 will be administered at protocol defined dose.
Part 1d: Food-Effect
Evaluate food effect on drug exposure as defined in the protocol.
INCB186748
INCB186748 will be administered at protocol defined dose.
Part 2a: Dose Escalation combination
INCB186748 in combination at the protocol-defined dose strength based on cohort assignment.
INCB186748
INCB186748 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
GEMNabP
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
Part 2b: Dose Expansion combination
INCB186748 in combination at the protocol-defined dose strength based on cohort assignment.
INCB186748
INCB186748 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
GEMNabP
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
Interventions
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INCB186748
INCB186748 will be administered at protocol defined dose.
Cetuximab
Cetuximab will be administered at protocol defined dose.
GEMNabP
GEMNabP will be administered at protocol defined dose.
mFOLFIRINOX
mFOLFIRINOX will be administered at protocol defined dose.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Incyte Medical Monitor
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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UCLA Healthcare Hematology-Oncology
Santa Monica, California, United States
Sarah Cannon Research Institue At Healthone
Denver, Colorado, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
Scri Oncology Partners
Nashville, Tennessee, United States
Md Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
Other Identifiers
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2024-519018-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
INCB186748-101
Identifier Type: -
Identifier Source: org_study_id
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