A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies

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Updated on 10 May 2022

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carcinoma

ovarian cancer

metastatic cervical cancer

urothelial carcinoma

Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies. This investigational intervention treatment uses a single biological drug and is conducted in two parts.

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.

Description

Contact Incyte Corporation Call Center (US):

1.855.463.3463

medinfo@incyte.com

Details

Condition	SCLC, Melanoma, Colorectal Cancer, SCCHN, Ovarian Cancer, Mesothelioma, Small Cell Lung Cancer, DLBCL, Gastric Cancer, Urothelial Carcinoma, Esophageal Cancer, Hepatocellularcarcinoma, Merkel Cell Carcinoma, Endometrial Cancer, Breast Cancer, NSCLC, Cervical Cancer, RCC
Clinical Study Identifier	TX218245
Last Modified on	10 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Years and older
	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

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A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies