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
NCT ID: NCT02908906
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
413 participants
INTERVENTIONAL
2016-11-21
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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JNJ-63723283
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenous (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses, dose administration routes (subcutaneous \[SC\] or IV), and dose schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1. In Part 3, participants will receive JNJ-63723283 to evaluate pharmacokinetic (PK), pharmacodynamic (PD) and safety. In Part 4, participants will receive JNJ-63723283 at the dose level determined in Part 3. Additional cohorts may be enrolled in Part 4.
JNJ-63723283
JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Interventions
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JNJ-63723283
JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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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
Countries
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References
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Felip E, Moreno V, Morgensztern D, Curigliano G, Rutkowski P, Trigo JM, Calvo A, Kowalski D, Cortinovis D, Plummer R, Maio M, Ascierto PA, Vladimirov VI, Cervantes A, Zudaire E, Hazra A, T'jollyn H, Bandyopadhyay N, Greger JG, Attiyeh E, Xie H, Calvo E. First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Cancer Chemother Pharmacol. 2022 Apr;89(4):499-514. doi: 10.1007/s00280-022-04414-6. Epub 2022 Mar 17.
Other Identifiers
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63723283LUC1001
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002017-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506144-16-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CR108223
Identifier Type: -
Identifier Source: org_study_id