A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

Incyte

Status and phase: Completed; Phase 1

Conditions: Esophageal Cancer; Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]); Melanoma (Uveal Melanoma Excluded); Urothelial Carcinoma; Diffuse Large B-cell Lymphoma; Ovarian Cancer; Merkel Cell Carcinoma; Non-small Cell Lung Cancer (NSCLC); MSI-high Colorectal Cancer; Renal Cell Carcinoma (RCC); Microsatellite Instability (MSI)-High Endometrial Cancer; Squamous Cell Carcinoma of the Head and Neck (SCCHN); Triple-negative Breast Cancer; Hepatocellular Carcinoma; Mesothelioma; Small Cell Lung Cancer (SCLC); Cervical Cancer

Treatments: Biological: INCAGN02385

Study type: Interventional

Funder types: Industry

Identifiers

NCT03538028

INCAGN 2385-101

Details and patient eligibility

About

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

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

INCAGN02385

Experimental group

Description:

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.

Treatment:

Biological: INCAGN02385