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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519018-30-00 | Registry Identifier | EU CT Number |
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The purpose of this study is to evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
|
| Part 1b: Dose Expansion monotherapy | Experimental | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
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| Part 1c: Pharmacodynamic cohort | Experimental | INCB186748 at the protocol-defined dose strength based on cohort assignment. |
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| Part 1d: Food-Effect | Experimental | Evaluate food effect on drug exposure as defined in the protocol. |
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| Part 2a: Dose Escalation combination | Experimental | INCB186748 in combination at the protocol-defined dose strength based on cohort assignment. |
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| Part 2b: Dose Expansion combination |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB186748 | Drug | INCB186748 will be administered at protocol defined dose. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose Limiting Toxicities (DLTs) | Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. | Up to 28 days |
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event occurring after the first dose of study drug up to 30 days (for INCB186748 as monotherapy and in combination with GEMNabP or mFOLFIRINOX) and 60 days (for INCB186748 in combination with cetuximab) after the last dose of INCB186748. | Up to approximately 12 months and 60 days |
| Number of participants with TEAEs leading to dose modification or discontinuation | Number of participants with TEAEs leading to dose modification or discontinuation. | Up to approximately 12 months and 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| INCB186748 pharmacokinetic (PK) in Plasma | INCB186748 concentration in plasma. | Up to approximately 12 months |
| Objective Response Rate (ORR) | Defined as having a best overall Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. |
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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
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
Combination Group 2 (INCB186748 in combination with GEMNabP) and
Combination Group 3 (INCB186748 in combination with mFOLFIRINOX):
Measurable disease according to RECIST v1.1.
ECOG performance status score of 0 or 1.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Healthcare Hematology-Oncology | Santa Monica | California | 90404 | United States | ||
| Sarah Cannon Research Institue At Healthone |
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| Label | URL |
|---|---|
| A Study to Evaluate INCB186748 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | View source |
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| Experimental |
INCB186748 in combination at the protocol-defined dose strength based on cohort assignment. |
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| Cetuximab | Drug | Cetuximab will be administered at protocol defined dose. |
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| GEMNabP | Drug | GEMNabP will be administered at protocol defined dose. |
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| mFOLFIRINOX | Drug | mFOLFIRINOX will be administered at protocol defined dose. |
|
| Up to approximately 12 months |
| Disease Control Response (DCR) | Defined as having a best overall response of CR, PR, or Stable Disease (SD) as determined by the investigator by radiographic disease assessment according to RECIST v1.1. | Up to approximately 12 months |
| Duration of Response (DOR) | Defined as the time from earliest date of disease response (Completed Response or Partial Response) until earliest date of disease progression as determined by the investigator by radiographic disease assessment according to RECIST v1.1 or death due to any cause if occurring sooner than progression. | Up to approximately 12 months |
| 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 |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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