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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-523130-11-00 | Registry Identifier | EU CT Number |
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A study to evaluate the safety and tolerability of INCA036873 in participants with advanced solid tumors and hematological malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a Dose Escalation | Experimental | INCA036873 will be administered at the protocol defined dose. |
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| Part 1b Dose Expansion | Experimental | INCA036873 will be administered at the protocol defined dose. |
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| Part 1c Pharmacodynamic Cohort | Experimental | INCA036873 will be administered at the protocol defined dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCA036873 | Drug | Intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1A : Occurrence of Dose Limiting Toxicities (DLTs) | Toxicities occurring during the first study drug infusion and continues through 28 days as defined in the protocol. DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria. | Up to Day 28 |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | TEAE is any Adverse Event (AE) either reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to approximately 2 years and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Parameter: Cmax of INCA036873 | Defined as maximum observed plasma concentration of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: Tmax of INCA036873 |
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Inclusion Criteria:
Age ≥18 years.
ECOG performance status of 0 or 1.
Histologically confirmed:
Disease progression, relapse, or refractory to prior therapy:
Measurable disease by RECIST v1.1 (ccRCC), Lugano 2014 (lymphomas), or ISCL/USCLC/EORTC (CTCL).
Tumor tissue available for central testing.
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 Study Monitor | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States | |
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| Label | URL |
|---|---|
| A Study to Evaluate INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies | View source |
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Defined as the time to reach the maximum plasma concentration of INCA036873.
| Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: Cmin of INCA036873 | Defined as the minimum observed plasma concentration of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: AUC(0-t) of INCA036873 | Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: AUC 0-∞ of INCA036873 | Defined as the area under the concentration-time curve from 0 to infinity of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: CL of INCA036873 | Defined as the apparent oral dose clearance of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: Vz of INCA036873 | Defined as the apparent oral dose volume of distribution of INCA036873. | Up to approximately 2 years and 90 days |
| Pharmacokinetics Parameter: t1/2 of INCA036873 | Defined as the apparent terminal phase disposition half-life of INCA036873. | Up to approximately 2 years and 90 days |
| Objective response | Defined as a Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR), as assessed by the investigator. | Up to approximately 2 years |
| Disease control | Defined as a BOR of CR, PR, or Stable Disease (SD), as assessed by the investigator. | Up to approximately 2 years |
| Duration of Response (DOR) | Defined as the time from the earliest date of a documented objective response (CR or PR) to the earliest date of disease progression (per investigator assessment using the appropriate criteria) or death from any cause, whichever occurs first. | Up to approximately 2 years |
| University of California San Diego Medical Center, Moores Cancer Center |
| Not yet recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| University of Michigan | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
| The University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
| Memorial Sloan Kettering Cancer Center | Not yet recruiting | New York | New York | 10021 | United States |
| Scri Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Medical Center | Not yet recruiting | Nashville | Tennessee | 37232 | United States |
| Md Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| Macquarie University Hospital | Recruiting | Sydney | New South Wales | 02109 | Australia |
| Princess Alexandra Hospital Australia | Recruiting | Woolloongabba | Queensland | 04102 | Australia |
| Cancer Research Sa | Recruiting | Adelaide | South Australia | 05000 | Australia |
| Peter Maccallum Cancer Centre-Royal Melbourne Hospital | Recruiting | Melbourne | Victoria | 03000 | Australia |
| Cliniques Universitaires Ucl Saint-Luc | Not yet recruiting | Brussels | 01200 | Belgium |
| Universitair Ziekenhuis Antwerpen | Not yet recruiting | Edegem | 02650 | Belgium |
| Universitair Ziekenhuis Gent (Uz Gent) | Not yet recruiting | Ghent | 09000 | Belgium |
| Universitair Ziekenhuis Leuven | Not yet recruiting | Leuven | 03000 | Belgium |
| Aarhus University Hospital | Not yet recruiting | Aarhus | 08200 | Denmark |
| Rigshospitalet Uni of Hospital of Copenhagen | Not yet recruiting | Copenhagen | DK-2100 | Denmark |
| Aou Policlinico S. Orsola-Malpighi | Not yet recruiting | Bologna | 40138 | Italy |
| Fondazione Irccs Istituto Nazionale Dei Tumori | Not yet recruiting | Milan | 20133 | Italy |
| Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore | Not yet recruiting | Rome | 00168 | Italy |
| Centro Ricerche Cliniche Di Verona | Not yet recruiting | Verona | 37134 | Italy |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D002292 | Carcinoma, Renal Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D016393 | Lymphoma, B-Cell |
| D008223 | Lymphoma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016399 | Lymphoma, T-Cell |
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