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Completed

NCT Number: NCT03538028

A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

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

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Key information

Conditions

Cervical Cancer Adenocarcinoma Adenoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Merkel Cell Carcinoma, Neuroendocrine Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma, Transitional Cell DNA Virus Infections Diffuse Large B-cell Lymphoma Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ]) Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Genomic Instability Gonadal Disorders Head and Neck Neoplasms Hemic and Lymphatic Diseases Hepatocellular Carcinoma Immune System Diseases Immunoproliferative Disorders Infections Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders MSI-high Colorectal Cancer Male Urogenital Diseases Melanoma Melanoma (Uveal Melanoma Excluded) Merkel Cell Carcinoma Mesothelioma Microsatellite Instability Microsatellite Instability (MSI)-High Endometrial Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer (NSCLC) Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Polyomavirus Infections Recurrence Renal Cell Carcinoma (RCC) Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases 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) Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-negative Breast Cancer Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinic and Research Center, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INCAGN02385

Biological

INCAGN02385 administered as an intravenous infusion over 30 minutes.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Incyte Biosciences International Sàrl

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 25, 2018
Registry last updated
Oct 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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