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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-507091-47-00 | Registry Identifier | EU CT Number |
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This study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: Dose Escalation monotherapy | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
|
| Part 1b: Dose Expansion monotherapy | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
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| Part 1c: Pharmacodynamic cohort | Experimental | INCB161734 at the protocol-defined dose strength based on cohort assignment. |
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| Part 2a: Dose Escalation combination | Experimental | INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. |
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| Part 2b: Dose Expansion combination | Experimental | INCB161734 in combination at the protocol-defined dose strength based on cohort assignment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCB161734 | Drug | INCB161734 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 after first dose of study drug monotherapy and in combination with cetuximab and retifanlimab. | Up to 2 years and 90 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 2 years and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| INCB161734 pharmacokinetic (PK) in Plasma | INCB161734 concentration in plasma. | Up to approximately 90 days |
| 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:
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Incyte Medical Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Hospital | Recruiting | Phoenix | Arizona | 85054 | United States | |
| Stanford University |
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| Label | URL |
|---|---|
| A Study to Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation | View source |
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| Part 1d: Food-Effect | Experimental | Evaluate food effect on drug exposure as defined in the protocol. |
|
| Cetuximab | Drug | Cetuximab will be administered at protocol defined dose. |
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| Retifanlimab | Drug | Retifanlimab 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. |
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| FOLFOX | Drug | FOLFOX will be administered at protocol defined dose. |
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| FOLFIRI | Drug | FOLFIRI will be administered at protocol defined dose. |
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| INCA33890 | Drug | INCA33890 will be administered at protocol defined dose. |
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| Up to 2 years |
| 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 2 years |
| 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 2 years |
| Recruiting |
| Palo Alto |
| California |
| 94305 |
| United States |
| UCLA Healthcare Hematology-Oncology | Recruiting | Santa Monica | California | 90404 | United States |
| Sarah Cannon Research Institue At Healthone | Recruiting | Denver | Colorado | 80218 | United States |
| Mayo Clinic Florida | Withdrawn | Jacksonville | Florida | 32224 | United States |
| Florida Cancer Specialists | Recruiting | Sarasota | Florida | 34232 | United States |
| Florida Cancer Specialists | Withdrawn | Sarasota | Florida | 34232 | United States |
| Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins | Recruiting | Baltimore | Maryland | 21287 | United States |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Withdrawn | Rochester | Minnesota | 55905 | United States |
| Hackensack University Medical Center | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10022 | United States |
| Jefferson University Hospitals | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Scri Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Md Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Chris Obrien Lifehouse | Recruiting | Camperdown | New South Wales | 02050 | Australia |
| St Vincent'S Hospital Sydney | Recruiting | Darlinghurst | New South Wales | 02010 | Australia |
| Peter Maccallum Cancer Centre | Recruiting | Melbourne | Victoria | 03000 | Australia |
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 03004 | Australia |
| Linear Clinical Research | Recruiting | Nedlands | Western Australia | 06009 | Australia |
| Cliniques Universitaires Ucl Saint-Luc | Recruiting | Brussels | 01200 | Belgium |
| Universitair Ziekenhuis Antwerpen (Uza) | Recruiting | Edegem | 02650 | Belgium |
| Universitair Ziekenhuis (Uz) Leuven | Recruiting | Leuven | 03000 | Belgium |
| The Ottawa Hospital Cancer Center | Recruiting | Ottawa | Ontario | K1H 8L6 | Canada |
| Princess Margaret Cancer Center | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Centre Leon Berard | Recruiting | Lyon | 69373 | France |
| Universitaire Du Cancer de Toulouse Institut Claudius Regaud Iuct-Oncopole | Recruiting | Toulouse | 31059 | France |
| Institut Gustave Roussy | Recruiting | Villejuif | 94805 | France |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Recruiting | Milan | 20133 | Italy |
| Irccs Istituto Clinico Humanitas | Recruiting | Rozzano | 20089 | Italy |
| Centro Ricerche Cliniche Di Verona | Recruiting | Verona | 37134 | Italy |
| National Cancer Center Hospital East | Recruiting | Chiba | 277-0882 | Japan |
| The Cancer Institute Hospital of Jfcr | Recruiting | Tokyo | 135-0063 | Japan |
| Hospital General Universitario Vall D Hebron | Recruiting | Barcelona | 08035 | Spain |
| Fundacion Jimenez Diaz | Recruiting | Madrid | 28040 | Spain |
| Hospital Universitario Quironsalud Madrid | Completed | Madrid | 28223 | Spain |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| 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 |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| C410216 | Folfox protocol |
| C480833 | IFL protocol |
| 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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