A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

October 28, 2020 updated by: Incyte Biosciences International Sàrl

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

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 Clinic and Research Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack Medical Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

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:

  • 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.

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax of INCAGN02385
Time Frame: Up to 12 months
Maximum observed plasma concentration.
Up to 12 months
Tmax of INCAGN02385
Time Frame: Up to 12 months
Time to maximum plasma concentration.
Up to 12 months
Cmin of INCAGN02385
Time Frame: Up to 12 months
Minimum observed plasma concentration during the dosing interval.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

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

Sponsor

Incyte Biosciences International Sàrl

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)

June 18, 2018

Primary Completion (ACTUAL)

October 7, 2020

Study Completion (ACTUAL)

October 7, 2020

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 28, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INCAGN 2385-101

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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