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
Condition(s) studied
Investigational drug(s) / intervention(s)
JNJ-63723283: JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Study 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.
Eligibility
Primary outcome measure(s)
- Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT) — Up to 2 years 6 months
Frequency and severity of dose-limiting toxicity will be reported. - Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors — Up to 2 years 6 months
Objective Response Rate (ORR) is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1) criteria. - Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau]) — Up to 2 years 6 months
AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.
Trial sites (20)
| Facility | City | Region | Status |
|---|---|---|---|
| — | St Louis | Missouri | |
| — | Pittsburgh | Pennsylvania | |
| — | 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 |
More Janssen Research & Development, LLC trials in Sweden
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02908906 on ClinicalTrials.gov ↗ ← All trials in Sweden