A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies
1 other identifier
interventional
40
1 country
4
Brief Summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02390 in participants with select advanced malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2018
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
September 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2021
CompletedNovember 15, 2021
November 1, 2021
2.9 years
August 28, 2018
November 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of treatment-emergent adverse events
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)
PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.
Up to approximately 1 month
Secondary Outcomes (10)
Cmax of INCAGN02390
Up to 12 months
Tmax of INCAGN02390
Up to 12 months
Cmin of INCAGN02390
Up to 12 months
AUC0-t of INCAGN02390
Up to 12 months
Objective response rate
Up to 12 months
- +5 more secondary outcomes
Study Arms (1)
INCAGN02390
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Angeles Clinical and Research Institute
Los Angeles, California, 90025, United States
University of Mississippi
Jackson, Mississippi, 39216, United States
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
Carolina BioOncology
Huntsville, North Carolina, 28078, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nawel Bourayou, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2018
First Posted
August 29, 2018
Study Start
September 24, 2018
Primary Completion
August 18, 2021
Study Completion
August 18, 2021
Last Updated
November 15, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share