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A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

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ClinicalTrials.gov Identifier: NCT03652077
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.

Condition or disease Intervention/treatment Phase
Cervical Cancer Gastric Cancer Stomach Cancer Gastroesophageal Junction Cancer Esophageal Cancer Hepatocellular Carcinoma Melanoma Uveal Melanoma Merkel Cell Carcinoma Mesothelioma MSI Non-small Cell Lung Cancer NSCLC Ovarian Cancer Squamous Cell Carcinoma of the Head and Neck Small Cell Lung Cancer Renal Cell Carcinoma RCC Triple-negative Breast Cancer Urothelial Carcinoma Mismatch Repair Deficiency Drug: INCAGN02390 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 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 INCAGN02390 in Participants With Select Advanced Malignancies
Actual Study Start Date : August 29, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: INCAGN02390 Drug: INCAGN02390
Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or PAD. Part 2: INCAGN02390 administered Q2W or Q4W at the recommended dose(s) from Part 1.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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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:

  • 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.

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): NCT03652077


Contacts
Contact: Incyte Corporation Call Center (US) 1.855.463.3463 medinfo@incyte.com

Locations
United States, California
The Angeles Clinical and Research Institute Not yet recruiting
Los Angeles, California, United States, 90025
United States, Mississippi
University of Mississippi Not yet recruiting
Jackson, Mississippi, United States, 39216
United States, North Carolina
Carolina BioOncology Recruiting
Huntsville, North Carolina, United States, 28078
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: John Janik, MD Incyte Corporation

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT03652077     History of Changes
Other Study ID Numbers: INCAGN 2390-101
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 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:
Advanced malignancies
immunoglobulin (Ig)G1k monoclonal antibody
T-cell immunoglobulin and mucin domain 3 (TIM-3)

Additional relevant MeSH terms:
Carcinoma
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Melanoma
Carcinoma, Squamous Cell
Neoplasms
Carcinoma, Hepatocellular
Stomach Neoplasms
Uterine Cervical Neoplasms
Carcinoma, Renal Cell
Esophageal Neoplasms
Small Cell Lung Carcinoma
Mesothelioma
Triple Negative Breast Neoplasms
Carcinoma, Transitional Cell
Head and Neck Neoplasms
Carcinoma, Merkel Cell
Brain Neoplasms
Neoplastic Syndromes, Hereditary
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neuroendocrine Tumors