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The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INCAGN02390 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INCAGN02390 | Drug | Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment-emergent adverse events | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to 12 months |
| Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only) | PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active. | Up to approximately 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of INCAGN02390 | Maximum observed plasma or serum concentration. | Up to 12 months |
| Tmax of INCAGN02390 | Time to maximum concentration. |
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Inclusion Criteria:
Exclusion Criteria:
Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.
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| Name | Affiliation | Role |
|---|---|---|
| Nawel Bourayou, MD | Incyte Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Angeles Clinical and Research Institute | Los Angeles | California | 90025 | United States | ||
| University of Mississippi |
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| Up to 12 months |
| Cmin of INCAGN02390 | Minimum observed plasma or serum concentration over the dose interval. | Up to 12 months |
| AUC0-t of INCAGN02390 | Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t. | Up to 12 months |
| Objective response rate | Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. | Up to 12 months |
| Duration of response | Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression. | Up to 12 months |
| Disease control rate | Defined as percentage of participants having CR, PR, or stable disease as best on-study response. | Up to 12 months |
| Progression-free survival | Defined as the time from date of first dose of study drug until the earliest date of disease progression (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression. | Up to 12 months |
| Level of binding of INCAGN02390 to TIM-3 | Assessed from participant whole blood samples. | Up to approximately 3 months |
| Immunogenicity of INCAGN02390 | Defined as the occurrence of specific ADA to INCAGN02390. | Up to 12 months |
| Jackson |
| Mississippi |
| 39216 |
| United States |
| Hackensack Medical Center | Hackensack | New Jersey | 07601 | United States |
| Carolina BioOncology | Huntsville | North Carolina | 28078 | United States |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D013274 | Stomach Neoplasms |
| D004938 | Esophageal Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D008545 | Melanoma |
| D000098943 | Uveal Melanoma |
| D015266 | Carcinoma, Merkel Cell |
| D008654 | Mesothelioma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D010051 | Ovarian Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D055752 | Small Cell Lung Carcinoma |
| D002292 | Carcinoma, Renal Cell |
| D064726 | Triple Negative Breast Neoplasms |
| D002295 | Carcinoma, Transitional Cell |
| C536928 | Turcot syndrome |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D000236 | Adenoma |
| D018301 | Neoplasms, Mesothelial |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002294 | Carcinoma, Squamous Cell |
| D007680 | Kidney Neoplasms |
| D014571 | Urologic Neoplasms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
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