A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

November 12, 2021 updated by: Incyte Corporation

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • The Angeles Clinical and Research Institute
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
    • North Carolina
      • Huntsville, North Carolina, United States, 28078
        • Carolina Biooncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: INCAGN02390
Drug: INCAGN02390
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
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.
Up to approximately 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of INCAGN02390
Time Frame: Up to 12 months
Maximum observed plasma or serum concentration.
Up to 12 months
Tmax of INCAGN02390
Time Frame: Up to 12 months
Time to maximum concentration.
Up to 12 months
Cmin of INCAGN02390
Time Frame: Up to 12 months
Minimum observed plasma or serum concentration over the dose interval.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
Level of binding of INCAGN02390 to TIM-3
Time Frame: Up to approximately 3 months
Assessed from participant whole blood samples.
Up to approximately 3 months
Immunogenicity of INCAGN02390
Time Frame: Up to 12 months
Defined as the occurrence of specific ADA to INCAGN02390.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Incyte Corporation

Investigators

  • Study Director: Nawel Bourayou, MD, Incyte Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 24, 2018

Primary Completion (Actual)

August 18, 2021

Study Completion (Actual)

August 18, 2021

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

August 28, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

November 15, 2021

Last Update Submitted That Met QC Criteria

November 12, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAGN 2390-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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