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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
Sponsor: Janssen Research & Development, LLC
Summary
The Primary purpose of this study is to identify the recommended Phase 2 dose \[RP2D(s)\] for JNJ-63723283 in Part 1, 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, to determine one or more additional RP2Ds in Parts 3 and 4.
Official title: A First-in-Human, Open-label, Phase 1/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects With Advanced Cancers
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
413
Start Date
2016-11-21
Completion Date
2026-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
JNJ-63723283
JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Locations (20)
St Louis, Missouri, United States
Pittsburgh, Pennsylvania, United States
Chisinau, Moldova
Bialystok, Poland
Warsaw, Poland
Moscow, Russia
Pyatigorsk, Russia
Saint Petersburg, Russia
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Málaga, Spain
Pamplona, Spain
Seville, Spain
Valencia, Spain
Gothenburg, Sweden
Glasgow, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Newcastle upon Tyne, United Kingdom