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A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

Brief Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.

Tracking Information
First Received DateMay 15, 2018
Last Changed DateAugust 27, 2018
Start DateJune 18, 2018
Anticipated Primary Completion DateMay 2020
Primary Outcome Measures

Number of treatment-emergent adverse events (TEAEs) [Time Frame: Up to 12 months]

Secondary Outcome Measures

Cmax of INCAGN02385 [Time Frame: Up to 12 months]

Tmax of INCAGN02385 [Time Frame: Up to 12 months]

Cmin of INCAGN02385 [Time Frame: Up to 12 months]

AUC0-t of INCAGN02385 [Time Frame: Up to 12 months]

Objective response rate (ORR) in participants with advanced or metastatic solid tumors [Time Frame: Up to 12 months]

Disease control rate (DCR) in participants with advanced or metastatic solid tumors [Time Frame: Up to 12 months]

Duration of response (DOR) in participants with advanced or metastatic solid tumors [Time Frame: Up to 12 months]

Progression-free survival (PFS) in participants with advanced or metastatic solid tumors [Time Frame: Up to 12 months]

ORR in participants with diffuse large B-cell lymphoma (DLBCL) [Time Frame: Up to 12 months]

DOR in participants with DLBCL [Time Frame: Up to 12 months]

PFS in participants with DLBCL [Time Frame: Up to 12 months]

Descriptive Information
PhasePhase 1
Study TypeInterventional
  • Cervical Cancer
  • Microsatellite Instability (MSI)-High Endometrial Cancer
  • Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])
  • Esophageal Cancer
  • Hepatocellular Carcinoma
  • Melanoma (Uveal Melanoma Excluded)
  • Merkel Cell Carcinoma
  • Mesothelioma
  • MSI-high Colorectal Cancer
  • Non-small Cell Lung Cancer (NSCLC)
  • Ovarian Cancer
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Small Cell Lung Cancer (SCLC)
  • Renal Cell Carcinoma (RCC)
  • Triple-negative Breast Cancer
  • Urothelial Carcinoma
  • Diffuse Large B-cell Lymphoma
  • Biological: INCAGN02385
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment55
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Incyte Corporation Call Center (US)
Phone: 1.855.463.3463
Eligibility Criteria

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 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.

Administrative Information
Responsible PartySponsor
SponsorIncyte Biosciences International Sàrl
Verification DateAugust 2018
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