A Safety and Tolerability Study of INCAGN02385 in Select Advanced Malignancies
A Phase 1 Open-Label, Dose-Escalation, Safety and Tolerability Study of INCAGN02385 in Participants With Select Advanced Malignancies
1 other identifier
interventional
22
1 country
4
Brief Summary
The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of INCAGN02385 in participants with advanced malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jun 2018
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 25, 2018
CompletedStudy Start
First participant enrolled
June 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedOctober 30, 2020
October 1, 2020
2.3 years
May 15, 2018
October 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (11)
Cmax of INCAGN02385
Up to 12 months
Tmax of INCAGN02385
Up to 12 months
Cmin of INCAGN02385
Up to 12 months
AUC0-t of INCAGN02385
Up to 12 months
Objective response rate (ORR) in participants with advanced or metastatic solid tumors
Up to 12 months
- +6 more secondary outcomes
Study Arms (1)
INCAGN02385
EXPERIMENTALPart 1: INCAGN02385 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation to determine the maximum tolerated dose or pharmacologically active dose. Part 2: INCAGN02385 administered Q2W or Q4W at the recommended dose(s) from Part 1.
Interventions
INCAGN02385 administered as an intravenous infusion over 30 minutes.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
The Angeles Clinic and Research Center
Los Angeles, California, 90025, United States
Hackensack Medical Center
Hackensack, New Jersey, 07601, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Janik, MD
Incyte Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 25, 2018
Study Start
June 18, 2018
Primary Completion
October 7, 2020
Study Completion
October 7, 2020
Last Updated
October 30, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share