A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

Phase 1

Completed

• Conditions: Gastric Cancer; Esophageal Cancer; RCC; Hepatocellular Carcinoma; Uveal Melanoma; Ovarian Cancer; Renal Cell Carcinoma; Triple-negative Breast Cancer; Gastroesophageal Junction Cancer; Melanoma
• Interventions: Drug: INCAGN02390

• Registration Number: NCT03652077
• Lead Sponsor: Incyte Corporation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Study Start: 2018-09-24
• Primary Completion: 2021-08-18
• Study Completion: 2021-08-18
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INCAGN02390	INCAGN02390	-

Primary Outcome Measures

Name	Time	Method
Number of treatment-emergent adverse events	Up to 12 months	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Maximum tolerated dose or pharmacologically active dose (PAD) of INCAGN02390 (Part 1 only)	Up to approximately 1 month	PAD defined as a dose that achieves a level of receptor occupancy considered to be biologically active.

Secondary Outcome Measures

Name	Time	Method
Tmax of INCAGN02390	Up to 12 months	Time to maximum concentration.
Cmax of INCAGN02390	Up to 12 months	Maximum observed plasma or serum concentration.
Cmin of INCAGN02390	Up to 12 months	Minimum observed plasma or serum concentration over the dose interval.
AUC0-t of INCAGN02390	Up to 12 months	Area under the plasma or serum concentration-time curve from time = 0 to the last measurable concentration at time = t.
Objective response rate	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.
Duration of response	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.
Disease control rate	Up to 12 months	Defined as percentage of participants having CR, PR, or stable disease as best on-study response.
Progression-free survival	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.
Level of binding of INCAGN02390 to TIM-3	Up to approximately 3 months	Assessed from participant whole blood samples.
Immunogenicity of INCAGN02390	Up to 12 months	Defined as the occurrence of specific ADA to INCAGN02390.

Trial Locations

Locations (4)

The Angeles Clinical and Research Institute; 🇺🇸 Los Angeles, California, United States

Hackensack Medical Center; 🇺🇸 Hackensack, New Jersey, United States

University of Mississippi; 🇺🇸 Jackson, Mississippi, United States

Carolina BioOncology; 🇺🇸 Huntsville, North Carolina, United States