A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies

STATUS

Recruiting

Updated on 10 May 2022

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cancer

advanced cancer

Summary

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with advanced malignancies.

This investigational intervention treatment uses a single biological drug and is conducted in two parts.

Part 1: INCAGN02390 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: INCAGN02390 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	Mesothelioma, Non-Small Cell Lung Cancer, Head and Neck Cancer Cervical Cancer Gastric Cancer Stomach Cancer Gastroesophageal Junction Cancer Esophageal Cancer Hepatocellular Carcinoma Melanoma Uveal Melanoma Merkel Cell Carcinoma Mesothelioma MSI NSCLC Ovarian Cancer Squamous Cell Carcinoma of the Head and Neck Small Cell Lung Cancer Renal Cell Carcinoma RCC Triple-negative Breast Cancer Urothelial Carcinoma Mismatch Repair Deficiency
Clinical Study Identifier	TX218264
Last Modified on	10 May 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent)
	Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment
	Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional)
	Eastern Cooperative Oncology Group performance status 0 or 1
	Willingness to avoid pregnancy or fathering children based on protocol-defined criteria
Exclusion Criteria
	Laboratory values at screening outside the protocol-defined ranges
	Administration of colony-stimulating factors 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
	Note: Examples of live vaccines include, but are not limited to, the
	following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies
	Bacillus Calmette-Guerin, and typhoid vaccine. Seasonal influenza vaccines for
	injection are generally killed virus vaccines and are allowed; however
	intranasal influenza vaccines are live-attenuated vaccines and are not
	allowed
	Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
	Known active central nervous system 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 with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent
	Evidence of active, noninfectious pneumonitis or history of interstitial lung disease
	Active infection requiring systemic therapy
	Evidence of active HBV or HCV infection
	Known history of HIV (HIV 1/2 antibodies)
	Known allergy or reaction to any component of study drug or formulation components
	Prior treatment with an anti-TIM-3 antibody for any indication

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A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies