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

  • STATUS
    Recruiting
Updated on 23 November 2020
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 Cervical Cancer, Small Cell Lung Cancer, Gastric Cancer
    Clinical Study IdentifierTX218245
    Last Modified on23 November 2020

    Eligibility

    Yes No Not Sure

    Inclusion Criteria

    Is your age greater than or equal to 18 yrs?
    Gender: Male or Female
    Do you have any of these conditions: Cervical Cancer or Gastric Cancer or Small Cell Lung Cancer?
    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
    Clear my responses

    How to participate?

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    Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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    If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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    Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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