A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
NCT ID: NCT03538028
Last Updated: 2020-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
22 participants
INTERVENTIONAL
2018-06-18
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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INCAGN02385
Part 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1.
INCAGN02385
INCAGN02385 administered as an intravenous infusion over 30 minutes.
Interventions
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INCAGN02385
INCAGN02385 administered as an intravenous infusion over 30 minutes.
Eligibility Criteria
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Inclusion Criteria
* 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 study.
* 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 biopsies.
* Eastern Cooperative Oncology Group performance status 0 or 1.
Exclusion Criteria
* 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 exceptions.
* 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.
18 Years
ALL
No
Sponsors
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Incyte Biosciences International Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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John Janik, MD
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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The Angeles Clinic and Research Center
Los Angeles, California, United States
Hackensack Medical Center
Hackensack, New Jersey, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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INCAGN 2385-101
Identifier Type: -
Identifier Source: org_study_id