Last updated on July 2019

A Study to Evaluate the Safety Pharmacokinetics Pharmacodynamics and Clinical Activity of JNJ-63723283 an Anti-PD-1 Monoclonal Antibody in Participants With Advanced Cancers


Brief description of study

The Primary purpose of this study is to identify the recommended Phase 2 dose [RP2D(s)] for JNJ-63723283 in Part 1 and to assess the anti-tumor activity of JNJ-63723283 at the RP2D(s) in participants with selected advanced cancers including non-small-cell lung cancer (NSCLC), melanoma, renal, bladder, small-cell lung cancer (SCLC), gastric/esophageal cancer, and high-level microsatellite instability (MSI-H) or mismatch repair-deficient (dMMR) colorectal cancer (CRC) in Part 2.

Detailed Study Description

This is a First in Human (FIH), open-label (all people involved know the identity of the intervention), multicenter (more than 1 study site) study in participants with advanced cancers to establish the recommended Phase 2 dose (RP2D[s]) for JNJ-63723283 in Part 1 and to evaluate the safety and efficacy of the RP2D(s) in Part 2. Subject participation will include a Screening Phase (28 Days) during which participant eligibility will be reviewed prior to administration of the first dose of JNJ-63723283; a Treatment Phase that will start at the first dose and continue until treatment is discontinued; and a Survival Follow-up Phase starting upon completion of the End-of-Treatment Visit and ends when the participant completes or withdraws from the study. The end of the study is defined as last study assessment for the last participant on study or if the sponsor terminates the study, whichever comes first. Participants safety will be monitored throughout the study.

Clinical Study Identifier: NCT02908906

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UPMC Cancer Centers

Pittsburgh, PA United States
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Pyatigorsky Oncology Dispensary

Pyatigorsk, Russian Federation
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BioEk, LLC

St. Petersburg, Russian Federation
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City Oncology Dispensary

St. Petersburg, Russian Federation
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