The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||August 29, 2018||Phase 1||Interventional|
Primary Outcome 1 - Measure: Number of treatment-emergent adverse events
Primary Outcome 1 - Time Frame: Up to 12 months
Primary Outcome 2 - Measure: Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
Primary Outcome 2 - Time Frame: Up to approximately 1 month
- 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
- 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.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: John Janik, MD
Role: Study Director
Affiliation: Incyte Corporation
Name: Incyte Corporation Call Center (US)
|The Angeles Clinical and Research Institute
Los Angeles, California 90025
|University of Mississippi
Jackson, Mississippi 39216
|Hackensack Medical Center
Hackensack, New Jersey 07601
Huntsville, North Carolina 28078