The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||June 18, 2018||Phase 1||Interventional|
Primary Outcome 1 - Measure: Number of treatment-emergent adverse events (TEAEs)
Primary Outcome 1 - Time Frame: Up to 12 months
- Locally advanced or metastatic disease; locally advanced disease must not be amenable
to resection with curative intent.
- Disease progression after treatment with available therapies that are known to confer
clinical benefit, or intolerant to treatment, or refuse noncurative standard
treatment. There is no limit to the number of prior treatment regimens.
- Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer,
gastric cancer (including stomach and GEJ), esophageal cancer, hepatocellular
carcinoma, melanoma (uveal melanoma excluded), Merkel cell carcinoma, mesothelioma,
MSI-high colorectal cancer, NSCLC, ovarian cancer, SCCHN, SCLC, RCC, triple-negative
breast cancer, and urothelial carcinoma, or alternative immunogenic tumor types with
medical monitor approval. Participants with DLBCL may participate in Part 2 of the
- Presence of measureable disease based on RECIST v1.1 for solid tumors or the Lugano
classification for DLBCL.
- Willingness and ability to safely undergo pretreatment and on-treatment tumor
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Laboratory and medical history parameters outside the protocol-defined range.
- Transfusion of blood products (including platelets or red blood cells) or
administration of colony-stimulating factors (including granulocyte colony-stimulating
factor, granulocyte macrophage colony-stimulating factor, or recombinant
erythropoietin) 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.
- Active autoimmune disease that required systemic treatment in the past.
- Known active CNS 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. See protocol-defined
- Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
- Active infection requiring systemic therapy.
- Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.
- Known history of HIV (HIV 1/2 antibodies).
- Prior treatment with an anti-LAG-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 Clinic and Research Center
Los Angeles, California 90025
|Hackensack Medical Center
Hackensack, New Jersey 07601
|Carolina BioOncology Institute
Huntersville, North Carolina 28078
|Vanderbilt University Medical Center
Nashville, Tennessee 37232