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A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

Brief Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.

Tracking Information
First Received DateAugust 28, 2018
Last Changed DateSeptember 11, 2018
Start DateAugust 29, 2018
Anticipated Primary Completion DateJune 2019
Primary Outcome Measures

Number of treatment-emergent adverse events [Time Frame: Up to 12 months]

Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only) [Time Frame: Up to approximately 1 month]

Secondary Outcome Measures

Cmax of INCAGN02390 [Time Frame: Up to 12 months]

Tmax of INCAGN02390 [Time Frame: Up to 12 months]

Cmin of INCAGN02390 [Time Frame: Up to 12 months]

AUC0-t of INCAGN02390 [Time Frame: Up to 12 months]

Objective response rate [Time Frame: Up to 12 months]

Duration of response [Time Frame: Up to 12 months]

Disease control rate [Time Frame: Up to 12 months]

Progression-free survival [Time Frame: Up to 12 months]

Level of binding of INCAGN02390 to TIM-3 [Time Frame: Up to approximately 3 months]

Immunogenicity of INCAGN02390 [Time Frame: Up to 12 months]

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Cervical Cancer
  • Gastric Cancer
  • Stomach Cancer
  • Gastroesophageal Junction Cancer
  • Esophageal Cancer
  • Hepatocellular Carcinoma
  • Melanoma
  • Uveal Melanoma
  • Merkel Cell Carcinoma
  • Mesothelioma
  • MSI
  • Non-small Cell Lung Cancer
  • NSCLC
  • Ovarian Cancer
  • Squamous Cell Carcinoma of the Head and Neck
  • Small Cell Lung Cancer
  • Renal Cell Carcinoma
  • RCC
  • Triple-negative Breast Cancer
  • Urothelial Carcinoma
  • Mismatch Repair Deficiency
Intervention
  • Drug: INCAGN02390
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment76
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Incyte Corporation Call Center (US)
Email: medinfo@incyte.com
Phone: 1.855.463.3463
Eligibility Criteria

Inclusion Criteria:

- Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).

- Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.

- Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).

- Eastern Cooperative Oncology Group performance status 0 or 1.

- Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

- Laboratory values at screening outside the protocol-defined ranges.

- Administration of colony-stimulating factors within 14 days before Study Day 1.

- Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug.

- Receipt of a live vaccine within 30 days of planned start of study drug.

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.

- Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).

- Known active central nervous system metastases and/or carcinomatous meningitis.

- Known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years of study entry with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.

- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.

- Active infection requiring systemic therapy.

- Evidence of active HBV or HCV infection.

- Known history of HIV (HIV 1/2 antibodies).

- Known allergy or reaction to any component of study drug or formulation components.

- Prior treatment with an anti-TIM-3 antibody for any indication.

Administrative Information
NCTIDNCT03652077
Responsible PartySponsor
SponsorIncyte Corporation
Verification DateSeptember 2018
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