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Brief Title: A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

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

INTRODUCTION

  • Org Study ID: INCAGN 2385-101
  • Secondary ID: N/A
  • NTC ID: NCT03538028
  • Sponsor: Incyte Biosciences International Sàrl

BRIEF SUMMARY


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


  • Overall Status
    Recruiting
  • Start Date
    June 18, 2018
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of treatment-emergent adverse events (TEAEs)

Primary Outcome 1 - Timeframe: Up to 12 months

CONDITION

  • 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

ELIGIBILITY


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.

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: John Janik, MD

Role: Study Director

Affiliation: Incyte Corporation

Overall Contact

Name: John Janik, MD

Phone: 1.855.463.3463

Email: medinfo@incyte.com

LOCATION

Facility Status Contact
Facility: The Angeles Clinic and Research Center
Los Angeles, California 90025
United States 		Status: Recruiting Contact: N/A
Facility: Hackensack Medical Center
Hackensack, New Jersey 07601
United States 		Status: Recruiting Contact: N/A
Facility: Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States 		Status: Recruiting Contact: N/A
Facility: Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States 		Status: Recruiting Contact: N/A

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