A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies

Ovarian Cancer Clinical Trial

Official title:

A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538028
• Other study ID #: INCAGN 2385-101
• Status: Completed
• Phase: Phase 1
• Start date: June 18, 2018
• Est. completion date: October 7, 2020

Study information

• Verified date: October 2020
• 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 INCAGN02385 in participants with advanced malignancies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 7, 2020
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent.

• Disease progression after treatment with available therapies that are known to confer clinical benefit, or intolerant to treatment, or refuse noncurative standard treatment. There is no limit to the number of prior treatment regimens.

• Participants with advanced or metastatic cervical cancer, MSI-high endometrial cancer, gastric cancer (including stomach and GEJ), esophageal cancer, hepatocellular carcinoma, melanoma (uveal melanoma excluded), Merkel cell carcinoma, mesothelioma, MSI-high colorectal cancer, NSCLC, ovarian cancer, SCCHN, SCLC, RCC, triple-negative breast cancer, and urothelial carcinoma, or alternative immunogenic tumor types with medical monitor approval. Participants with DLBCL may participate in Part 2 of the study.

• Presence of measureable disease based on RECIST v1.1 for solid tumors or the Lugano classification for DLBCL.

• Willingness and ability to safely undergo pretreatment and on-treatment tumor biopsies.

• Eastern Cooperative Oncology Group performance status 0 or 1.

Exclusion Criteria:

• Laboratory and medical history parameters outside the protocol-defined range.

• Transfusion of blood products (including platelets or red blood cells) or administration of colony-stimulating factors (including granulocyte colony-stimulating factor, granulocyte macrophage colony-stimulating factor, or recombinant erythropoietin) 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.

• Active autoimmune disease that required systemic treatment in the past.

• Known active CNS 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. See protocol-defined exceptions.

• Evidence of active, noninfectious pneumonitis or history of interstitial lung disease.

• Active infection requiring systemic therapy.

• Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.

• Known history of HIV (HIV 1/2 antibodies).

• Prior treatment with an anti-LAG-3 antibody for any indication.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Merkel Cell
• Cervical Cancer
• Diffuse Large B-cell Lymphoma
• Endometrial Neoplasms
• Esophageal Cancer
• Gastric Cancer (Including Stomach and Gastroesophageal Junction [GEJ])
• Hepatocellular Carcinoma
• Lung Neoplasms
• Lymphoma, Large B-Cell, Diffuse
• Melanoma
• Melanoma (Uveal Melanoma Excluded)
• Merkel Cell Carcinoma
• Mesothelioma
• Microsatellite Instability
• Microsatellite Instability (MSI)-High Endometrial Cancer
• MSI-high Colorectal Cancer
• Non-small Cell Lung Cancer (NSCLC)
• Ovarian Cancer
• Renal Cell Carcinoma (RCC)
• Small Cell Lung Cancer (SCLC)
• Small Cell Lung Carcinoma
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck (SCCHN)
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer
• Urothelial Carcinoma

Intervention

Biological:
• INCAGN02385
INCAGN02385 administered as an intravenous infusion over 30 minutes.

Locations

Country	Name	City	State
United States	Hackensack Medical Center	Hackensack	New Jersey
United States	Carolina BioOncology Institute	Huntersville	North Carolina
United States	The Angeles Clinic and Research Center	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Biosciences International Sàrl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment-emergent adverse events (TEAEs)	TEAE defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.	Up to 12 months
Secondary	Cmax of INCAGN02385	Maximum observed plasma concentration.	Up to 12 months
Secondary	Tmax of INCAGN02385	Time to maximum plasma concentration.	Up to 12 months
Secondary	Cmin of INCAGN02385	Minimum observed plasma concentration during the dosing interval.	Up to 12 months
Secondary	AUC0-t of INCAGN02385	Area under the single-dose plasma concentration-time curve from Hour 0 to the last quantifiable measurable plasma concentration.	Up to 12 months
Secondary	Objective response rate (ORR) in participants with advanced or metastatic solid tumors	Defined as the percentage of participants having complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.	Up to 12 months
Secondary	Disease control rate (DCR) in participants with advanced or metastatic solid tumors	Defined as percentage of participants having CR, PR, or stable disease (SD) as best on-study response.	Up to 12 months
Secondary	Duration of response (DOR) in participants with advanced or metastatic solid tumors	Defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression per RECIST v1.1 or death from any cause, if occurring sooner than progression.	Up to 12 months
Secondary	Progression-free survival (PFS) in participants with advanced or metastatic solid tumors	Defined as the time from date of first dose of study drug until the earliest date of disease progression per RECIST v1.1 or death from any cause if occurring sooner than progression.	Up to 12 months
Secondary	ORR in participants with diffuse large B-cell lymphoma (DLBCL)	Defined as the percentage of participants with a CR/complete metabolic response (CMR) or PR/partial metabolic response (PMR) per the Lugano Classification.	Up to 12 months
Secondary	DOR in participants with DLBCL	Defined as the time from first documented evidence of CR/CMR or PR/PMR until disease progression per radiographic disease assessment or death from any cause among participants who achieve an objective response.	Up to 12 months
Secondary	PFS in participants with DLBCL	Defined as the time from the date of the first dose of study drug until the earliest date of disease progression per radiographic disease assessment or death from any cause if occurring sooner than progression.	Up to 12 months