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 | Active Not Recruiting Phase 1

• 4 other identifiers: CR10822363723283LUC10012016-002017-222023-506144-16-00
• Study Type: interventional
• Target: 413
• Locations: 7 countries
• Sites: 20

Brief 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• Part 1: Frequency and Severity of Dose-Limiting Toxicity (DLT)

  Frequency and severity of dose-limiting toxicity will be reported.

  Up to 2 years 6 months

• Part 2: Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors

  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.

  Up to 2 years 6 months

• Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve from Time Zero to Dosing Interval (AUC [0-tau])

  AUC (0-tau) is defined as area under the serum concentration versus time curve from time zero to dosing interval.

  Up to 2 years 6 months

Secondary Outcomes (20)

• Parts 1, 2, 3, and 4 : Number of Participants With Adverse Events (AEs) as a Measure of Safety

  Up to 2 years 6 months

• Parts 1, 2 and 3, and 4: Maximum Observed Serum Concentration (Cmax)

  Up to 2 years 6 months

• Parts 1 and 2: Area Under the Serum Concentration Versus Time Curve Between time t1 and t2 (AUC [t1-t2])

  Up to 2 years 6 months

• Parts 1, 2 and 3: Elimination Half-Life (t1/2)

  Up to 2 years 6 months

• Parts 1 and 2: Total Systemic Clearance of (CL)

  Up to 2 years 6 months

Study Arms (1)

JNJ-63723283

EXPERIMENTAL

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.

Drug: JNJ-63723283

Interventions

JNJ-63723283 DRUG

JNJ-63723283 will be administered by IV infusion or SC injection or infusion.

Also known as: Cetrelimab

JNJ-63723283

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (20)

Unknown Facility

St Louis, Missouri, United States

Location

Unknown Facility

Pittsburgh, Pennsylvania, United States

Location

Unknown Facility

Chisinau, Moldova

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Pyatigorsk, Russia

Location

Unknown Facility

Saint Petersburg, Russia

Location

Unknown Facility

Badalona, Spain

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Málaga, Spain

Location

Unknown Facility

Pamplona, Spain

Location

Unknown Facility

Seville, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Gothenburg, Sweden

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 35298698 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2016
• First Posted: September 21, 2016
• Study Start: November 21, 2016
• Primary Completion: November 17, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

GB (4); US (2); PL (2); RU (3); SE (1); MO (1); ES (7)