A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Oct 30, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Incyte Biosciences International Sàrl
- Interventions being studied
- Biological: INCAGN02385
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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 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.
- 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 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- The Angeles Clinic and Research CenterLos Angeles, California
- Hackensack Medical CenterHackensack, New Jersey
- Carolina BioOncology InstituteHuntersville, North Carolina
- Vanderbilt University Medical CenterNashville, Tennessee
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 30, 2020. Always confirm current availability with the study team.