Clinical trial NCT03652077: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Keywords: Advanced malignancies
immunoglobulin (Ig)G1k monoclonal antibody
T-cell immunoglobulin and mucin domain 3 (TIM-3)
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: Up to 12 months
measure: Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)
timeFrame: Up to approximately 1 month
Secondary outcomes:
measure: Cmax of INCAGN02390
timeFrame: Up to 12 months
measure: Tmax of INCAGN02390
timeFrame: Up to 12 months
measure: Cmin of INCAGN02390
timeFrame: Up to 12 months
measure: AUC0-t of INCAGN02390
timeFrame: Up to 12 months
measure: Objective response rate
timeFrame: Up to 12 months
measure: Duration of response
timeFrame: Up to 12 months
measure: Disease control rate
timeFrame: Up to 12 months
measure: Progression-free survival
timeFrame: Up to 12 months
measure: Level of binding of INCAGN02390 to TIM-3
timeFrame: Up to approximately 3 months
measure: Immunogenicity of INCAGN02390
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Angeles Clinical and Research Institute
state: California
city: Jackson
country: United States
facility: University of Mississippi
state: Mississippi
city: Hackensack
country: United States
facility: Hackensack Medical Center
state: New Jersey
city: Huntsville
country: United States
facility: Carolina BioOncology
state: North Carolina
Study officials:
affiliation: Incyte Corporation
name: Nawel Bourayou, MD
role: STUDY_DIRECTOR
References: