A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies (NCT03538028) | Clinical Trial Compass
CompletedPhase 1
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
United States22 participantsStarted 2018-06-18
Plain-language summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 eryt…
What they're measuring
1
Number of treatment-emergent adverse events (TEAEs)