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A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03538028
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation ( 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.

Condition or disease Intervention/treatment Phase
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 Biological: INCAGN02385 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020


Arm Intervention/treatment
Experimental: INCAGN02385
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.
Biological: INCAGN02385
INCAGN02385 administered as an intravenous infusion over 30 minutes.




Primary Outcome Measures :
  1. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 12 months ]
    TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.


Secondary Outcome Measures :
  1. Cmax of INCAGN02385 [ Time Frame: Up to 12 months ]
    Maximum observed plasma concentration.

  2. Tmax of INCAGN02385 [ Time Frame: Up to 12 months ]
    Time to maximum plasma concentration.

  3. Cmin of INCAGN02385 [ Time Frame: Up to 12 months ]
    Minimum observed plasma concentration during the dosing interval.

  4. AUC0-t of INCAGN02385 [ Time Frame: Up to 12 months ]
    Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.

  5. Objective response rate (ORR) in participants with advanced or metastatic solid tumors [ Time Frame: Up to 12 months ]
    Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  6. Disease control rate (DCR) in participants with advanced or metastatic solid tumors [ Time Frame: Up to 12 months ]
    Defined as percentage of participants having CR, PR, or stable disease (SD) as best on-study response.

  7. Duration of response (DOR) in participants with advanced or metastatic solid tumors [ Time Frame: Up to 12 months ]
    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.

  8. Progression-free survival (PFS) in participants with advanced or metastatic solid tumors [ Time Frame: Up to 12 months ]
    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.

  9. ORR in participants with diffuse large B-cell lymphoma (DLBCL) [ Time Frame: Up to 12 months ]
    Defined as the percentage of participants with a CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) per the Lugano Classification.

  10. DOR in participants with DLBCL [ Time Frame: Up to 12 months ]
    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.

  11. PFS in participants with DLBCL [ Time Frame: Up to 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538028


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com
Contact: Incyte Corporation Call Center (ex-US) +800 00027423 globalmedinfo@incyte.com

Locations
United States, California
The Angeles Clinic and Research Center Recruiting
Los Angeles, California, United States, 90025
United States, New Jersey
Hackensack Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
United States, Tennessee
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Incyte Biosciences International Sàrl
Investigators
Study Director: John Janik, MD Incyte Corporation

Responsible Party: Incyte Biosciences International Sàrl
ClinicalTrials.gov Identifier: NCT03538028     History of Changes
Other Study ID Numbers: INCAGN 2385-101
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Incyte Corporation ( Incyte Biosciences International Sàrl ):
lymphocyte activation gene (LAG)
LAG-3
advanced solid tumor
metastatic solid tumor
relapsed/refractory DLCBL

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Colorectal Neoplasms
Carcinoma, Squamous Cell
Carcinoma, Hepatocellular
Stomach Neoplasms
Lymphoma, B-Cell
Uterine Cervical Neoplasms
Carcinoma, Renal Cell
Esophageal Neoplasms
Small Cell Lung Carcinoma
Lymphoma, Large B-Cell, Diffuse
Endometrial Neoplasms
Mesothelioma
Triple Negative Breast Neoplasms
Carcinoma, Transitional Cell
Head and Neck Neoplasms
Carcinoma, Merkel Cell
Microsatellite Instability
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic