Genitourinary & Gynecologic Cancer, Stomach or Esophageal Cancer, Esophageal cancer, Liver Cancer, Skin Cancer, Mesothelioma, Colorectal Cancer, Non Small Cell Lung Cancer, Head and Neck Cancer, Small Cell Lung Cancer, Kidney Cancer, Breast Cancer, Bladder Cancer, Lymphoma
A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
Incyte Study ID:
INCAGN 2385-101
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Biosciences International Sàrl
Collaborator:
N/A
Study Contact Information:
Clinical Study Purpose
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Jun 2018 - Oct 2020
TYPE
Interventional
PHASE
Phase 1
SEX
Female & Male
AGE
18+ years
ACCEPTS HEALTHY VOLUNTEERS
No
Clinical Study Locations
Name
Contact UsName
The Angeles Clinic and Research Center
Los Angeles, California, US, 90025
Name
Hackensack Medical Center
Hackensack, New Jersey, US, 07601
Name
Carolina BioOncology Institute
Huntersville, North Carolina, US, 28078
Name
Vanderbilt University Medical Center
Nashville, Tennessee, US, 37232
Key Inclusion and Exclusion Criteria
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.
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.
Protocol Summary
Incyte Study ID:
INCAGN 2385-101
Primary Purpose:
Treatment
Allocation:
N/A
Study Design:
Single Group Assignment
Masking:
None (Open Label)
Interventions:
Biological/Vaccine
Enrollment:
22
Primary Outcome
Open
Number of treatment-emergent adverse events (TEAEs)
Timeframe: Up to 12 months
Secondary Outcome
Open
Cmax of INCAGN02385
Timeframe: Up to 12 months
Tmax of INCAGN02385
Timeframe: Up to 12 months
Cmin of INCAGN02385
Timeframe: Up to 12 months
AUC0-t of INCAGN02385
Timeframe: Up to 12 months
Objective response rate (ORR) in participants with advanced or metastatic solid tumors
Timeframe: Up to 12 months
Disease control rate (DCR) in participants with advanced or metastatic solid tumors
Timeframe: Up to 12 months
Duration of response (DOR) in participants with advanced or metastatic solid tumors
Timeframe: Up to 12 months
Progression-free survival (PFS) in participants with advanced or metastatic solid tumors
Timeframe: Up to 12 months
ORR in participants with diffuse large B-cell lymphoma (DLBCL)
Timeframe: Up to 12 months
DOR in participants with DLBCL
Timeframe: Up to 12 months
PFS in participants with DLBCL
Timeframe: Up to 12 months