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Brief Title: A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies


  • Org Study ID: INCAGN 2390-101
  • Secondary ID: N/A
  • NTC ID: NCT03652077
  • Sponsor: Incyte Corporation


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

  • Overall Status
  • Start Date
    August 29, 2018
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure: Number of treatment-emergent adverse events

Primary Outcome 1 - Timeframe: Up to 12 months

Primary Outcome 2 - Measure: Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)

Primary Outcome 2 - Timeframe: Up to approximately 1 month


  • 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
  • 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


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

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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No


Name: John Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: John Janik, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com


Facility Status Contact
Facility: The Angeles Clinical and Research Institute
Los Angeles, California 90025
United States
Status: Recruiting Contact: N/A
Facility: University of Mississippi
Jackson, Mississippi 39216
United States
Status: Recruiting Contact: N/A
Facility: Hackensack Medical Center
Hackensack, New Jersey 07601
United States
Status: Recruiting Contact: N/A
Facility: Carolina BioOncology
Huntsville, North Carolina 28078
United States
Status: Recruiting Contact: N/A