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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03538028
Other study ID # INCAGN 2385-101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 18, 2018
Est. completion date October 7, 2020

Study information

Verified date October 2020
Source Incyte Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 7, 2020
Est. primary completion date October 7, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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.

Study Design


Related Conditions & MeSH terms

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

Intervention

Biological:
INCAGN02385
INCAGN02385 administered as an intravenous infusion over 30 minutes.

Locations

Country Name City State
United States Hackensack Medical Center Hackensack New Jersey
United States Carolina BioOncology Institute Huntersville North Carolina
United States The Angeles Clinic and Research Center Los Angeles California
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Incyte Biosciences International Sàrl

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of treatment-emergent adverse events (TEAEs) TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. Up to 12 months
Secondary Cmax of INCAGN02385 Maximum observed plasma concentration. Up to 12 months
Secondary Tmax of INCAGN02385 Time to maximum plasma concentration. Up to 12 months
Secondary Cmin of INCAGN02385 Minimum observed plasma concentration during the dosing interval. Up to 12 months
Secondary AUC0-t of INCAGN02385 Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration. Up to 12 months
Secondary Objective response rate (ORR) in participants with advanced or metastatic solid tumors Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Up to 12 months
Secondary Disease control rate (DCR) in participants with advanced or metastatic solid tumors Defined as percentage of participants having CR, PR, or stable disease (SD) as best on-study response. Up to 12 months
Secondary Duration of response (DOR) in participants with advanced or metastatic solid tumors Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression per RECIST v1.1 or death from any cause, if occurring sooner than progression. Up to 12 months
Secondary Progression-free survival (PFS) in participants with advanced or metastatic solid tumors Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1 or death from any cause if occurring sooner than progression. Up to 12 months
Secondary ORR in participants with diffuse large B-cell lymphoma (DLBCL) Defined as the percentage of participants with a CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) per the Lugano Classification. Up to 12 months
Secondary DOR in participants with DLBCL Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression per radiographic disease assessment or death from any cause among participants who achieve an objective response. Up to 12 months
Secondary PFS in participants with DLBCL Defined as the time from the date of the first dose of study drug until the earliest date of disease progression per radiographic disease assessment or death from any cause if occurring sooner than progression. Up to 12 months
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