A Safety and Tolerability Study of INCAGN02390 in Select Advanced Malignancies

Ovarian Cancer Clinical Trial

Official title:

A Phase 1, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02390 in Participants With Select Advanced Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652077
• Other study ID #: INCAGN 2390-101
• Status: Completed
• Phase: Phase 1
• Start date: September 24, 2018
• Est. completion date: August 18, 2021

Study information

• Verified date: November 2021
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 18, 2021
• Est. primary completion date: August 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Cervical Cancer
• Esophageal Cancer
• Gastric Cancer
• Gastroesophageal Junction Cancer
• Hepatocellular Carcinoma
• Lung Neoplasms
• Melanoma
• Merkel Cell Carcinoma
• Mesothelioma
• Mismatch Repair Deficiency
• MSI
• Neoplasms
• Non-small Cell Lung Cancer
• NSCLC
• Ovarian Cancer
• RCC
• Renal Cell Carcinoma
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck
• Stomach Cancer
• Stomach Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer
• Urothelial Carcinoma
• Uveal Melanoma

Intervention

Drug:
• INCAGN02390
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.

Locations

Country	Name	City	State
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Carolina BioOncology	Huntsville	North Carolina
United States	University of Mississippi	Jackson	Mississippi
United States	The Angeles Clinical and Research Institute	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

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