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Clinical Trials in Spain / NCT02908906
Active, not recruiting Phase 1/2

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

NCT02908906 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2016-11-21
Last updated
2026-08-31

Condition(s) studied

Neoplasms

Investigational drug(s) / intervention(s)

JNJ-63723283 →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Parts 1-4: Have an Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1 * Parts 1-4: Has thyroid function laboratory values within normal range * Parts 1-4: Females of childbearing potential must have a negative serum pregnancy test * Parts 1-4: Willing and able to adhere to the prohibitions and restrictions specified in this protocol * For Part 2 only: Participants enrolled into Part 2 must have tumor tissue available for correlative studies. Fresh tumor biopsy is preferred. Archival tissue must meet the following criteria: archival sections within 4 months of sectioning that have been stored at 2 degree to 8 degree Celsius in the dark or archival tumor blocks within 5 years of collection. Participants without tissues meeting the aforementioned archived tissue criteria must undergo a fresh biopsy * Parts 1 to 4: Have evaluable disease Exclusion Criteria: * Has uncontrolled intercurrent illness, including but not limited to ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure (New York Heart Association class III-IV), unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension or diabetes, or psychiatric illness/social situation that would limited compliance with study requirements * Has had prior treatment with an anti-Programmed-cell death receptor-1 (PD-1) antibody, anti-the ligand to programmed-cell death 1 (PD-L1) antibody or anti-the ligand to programmed-cell death 2 (PD-L2) antibody * Treatment with any local or systemic anti-neoplastic therapy, radiotherapy (excluding limited palliative radiation), or investigational anticancer agent within 14 days or 4 half lives, whichever is longer, up to a maximum wash-out period of 28 days prior to the initiation of study drug administration * Grade 3 or higher toxicity effects from previous treatment with immunotherapy * A female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this study or within 5 months after the last dose of study drug

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
— 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 Spain

Other trials for the same condition

Official registry record

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 Spain