Brief Title
A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies
Official Title
A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies
Brief Summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy
of INCAGN02390 in participants with select advanced malignancies.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of treatment-emergent adverse events
Secondary Outcome
Cmax of INCAGN02390
Condition
Cervical Cancer
Intervention
INCAGN02390
Study Arms / Comparison Groups
INCAGN02390
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
September 24, 2018
Completion Date
September 30, 2021
Primary Completion Date
September 30, 2021
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John Janik, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03652077
Organization ID
INCAGN 2390-101
Responsible Party
Sponsor
Study Sponsor
Incyte Corporation
Study Sponsor
John Janik, MD, Study Director, Incyte Corporation
Verification Date
March 2021