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Completed

NCT Number: NCT03652077

A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select 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 Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Eye Diseases Eye Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastroesophageal Junction Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Hepatocellular Carcinoma Infections Kidney Diseases Kidney Neoplasms Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms MSI Male Urogenital Diseases Melanoma Merkel Cell Carcinoma Mesothelioma Mismatch Repair Deficiency NSCLC Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Non-small Cell Lung Cancer Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Polyomavirus Infections RCC Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Small Cell Lung Cancer Small Cell Lung Carcinoma Squamous Cell Carcinoma of Head and Neck Squamous Cell Carcinoma of the Head and Neck Stomach Cancer Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Triple Negative Breast Neoplasms Triple-negative Breast Cancer Tumor Virus Infections Turcot syndrome Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Uveal Diseases Uveal Melanoma Uveal Neoplasms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Angeles Clinical and Research Institute, 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

  • Participants with locally advanced or metastatic tumors who are not eligible for any available therapy likely to convey clinical benefit (locally advanced disease must not be amenable to resection with curative intent).
  • Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit or who are intolerant to treatment.
  • Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies (core or excisional).
  • Eastern Cooperative Oncology Group performance status 0 or 1.
  • Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion criteria

  • Laboratory values at screening outside the protocol-defined ranges.
  • Administration of colony-stimulating factors 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.

Note: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox/zoster, yellow fever, rabies, Bacillus Calmette-Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live-attenuated vaccines and are not allowed.

  • Active autoimmune disease that required systemic treatment in the past (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs).
  • Known active central nervous system 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 with the exception of cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy, or cancers from which the participant has been disease-free for > 1 year, after treatment with curative intent.
  • Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.
  • Active infection requiring systemic therapy.
  • Evidence of active HBV or HCV infection.
  • Known history of HIV (HIV 1/2 antibodies).
  • Known allergy or reaction to any component of study drug or formulation components.
  • Prior treatment with an anti-TIM-3 antibody for any indication.

Treatment and study plan

INCAGN02390

Drug

Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.

Primary outcomes

  1. Number of treatment-emergent adverse events

    Time frame: Up to 12 months

    Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.

  2. Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)

    Time frame: Up to approximately 1 month

    PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.

Secondary outcomes

  1. Cmax of INCAGN02390

    Time frame: Up to 12 months

    Maximum observed plasma or serum concentration.

  2. Tmax of INCAGN02390

    Time frame: Up to 12 months

    Time to maximum concentration.

  3. Cmin of INCAGN02390

    Time frame: Up to 12 months

    Minimum observed plasma or serum concentration over the dose interval.

  4. AUC0-t of INCAGN02390

    Time frame: Up to 12 months

    Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.

  5. Objective response rate

    Time frame: Up to 12 months

    Defined as the percentage of participants having complete response (CR) or partial response (PR) determined by investigator assessment of radiographic disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  6. Duration of response

    Time frame: Up to 12 months

    Defined as time from earliest date of disease response (CR or PR) until earliest date of disease progression (determined by investigator assessment of radiographic disease per RECIST v1.1) or death from any cause, if occurring sooner than progression.

  7. Disease control rate

    Time frame: Up to 12 months

    Defined as percentage of participants having CR, PR, or stable disease as best on-study response.

  8. Progression-free survival

    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 (determined by investigator assessment of objective radiographic disease per RECIST v1.1) or death from any cause if occurring sooner than progression.

  9. Level of binding of INCAGN02390 to TIM-3

    Time frame: Up to approximately 3 months

    Assessed from participant whole blood samples.

  10. Immunogenicity of INCAGN02390

    Time frame: Up to 12 months

    Defined as the occurrence of specific ADA to INCAGN02390.

Sponsors and collaborators

Lead sponsor

Incyte Corporation

Industry

Registry information

Official study title

A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2018
Registry last updated
Nov 15, 2021

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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