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NCT Number: NCT02908906

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Chisinau, Moldova

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JNJ-63723283

Drug

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

Other names: Cetrelimab

Primary outcomes

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

    Time frame: Up to 2 years 6 months

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

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

    Time frame: 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.

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: Up to 2 years 6 months

    An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.

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

    Time frame: Up to 2 years 6 months

    The Cmax is the maximum observed serum concentration.

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

    Time frame: Up to 2 years 6 months

    AUC (t1-t2) is defined as the area under the serum concentration versus time curve between time t1 and t2.

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

    Time frame: Up to 2 years 6 months

    The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration.

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

    Time frame: Up to 2 years 6 months

    Total systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.

  6. Parts 1 and 2: Volume of Distribution at Steady-State (Vss)

    Time frame: Up to 2 years 6 months

    The Vss is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of JNJ-63723283 at steady state.

  7. Parts 1 and 2: Accumulation Ratio (R)

    Time frame: Up to 2 years 6 months

    The R is obtained by dividing AUC at two different time points.

  8. Parts 3 and 4: Average Concentration (Cavg) of JNJ-63723283

    Time frame: Up to 2 years 6 months

    Cavg of JNJ-63723283 will be reported.

  9. Parts 3 and 4: Area Under the Serum Concentration Versus Time Curve Between Time Zero and Time t (AUC [0-t])

    Time frame: Up to 2 years 6 months

    AUC (0-t) is defined as area under the serum concentration versus time curve between time zero and time t.

  10. Parts 3: Area Under the Serum Concentration Versus Time Curve from Time Zero to Infinity (AUC [0-Infinity])

    Time frame: Up to 2 years 6 months

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

  11. Parts 3 and 4: Concentration Observed at the Last Timepoint Prior to Dosing (Ctrough)

    Time frame: Up to 2 years 6 months

    Ctrough is defined as the concentration observed at the last timepoint prior to dosing.

  12. Parts 1, 2, 3, and 4: Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations

    Time frame: Up to 2 years 6 months

    Serum samples will be analyzed for antibodies to JNJ-63723283. The titer of the confirmed positive samples will be reported.

  13. Parts 1, 2, 3, and 4: Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC)

    Time frame: Up to 2 years 6 months

    ORR is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on irRC criteria.

  14. Parts 1, 2, 3, and 4: Duration of Response (DOR) per RECIST v1.1

    Time frame: Up to 2 years 6 months

    For Participants who achieve CR or PR, DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

  15. Parts 1, 2, 3, and 4: Duration of Response (DOR) per irRC

    Time frame: Up to 2 years 6 months

    For Participants who achieve CR or PR (defined by irRC), DOR will be calculated as time from initial response of CR or partial response (PR) to progressive disease or death due to underlying disease whichever comes first.

  16. Parts 1, 2, 3, and 4: Clinical Benefit Rate (CBR) per RECIST v1.1

    Time frame: Up to 2 years 6 months

    The CBR is defined as the percentage of participants who achieve CR, PR or stable disease (SD; greater than or equal to [>=] 24 weeks from the 1st study drug) based on RECIST v1.1 criteria.

  17. Parts 1, 2, 3, and 4: Clinical Benefit Rate per irRC

    Time frame: Up to 2 years 6 months

    The CBR is defined as the percentage of participants who achieve CR, PR or SD (>= 24 weeks from the 1st study drug) based on irRC criteria.

  18. Parts 1, 2, 3, and 4: Progression-free Survival (PFS) per RECIST v1.1

    Time frame: Up to 2 years 6 months

    The time from first dose of JNJ-63723283 to progressive disease as defined by RECIST v 1.1 or death due to any cause.

  19. Parts 1, 2, 3, and 4: Progression-free Survival (PFS) per irRC

    Time frame: Up to 2 years 6 months

    The time from first dose of JNJ-63723283 to progressive disease as defined by irRC or death due to any cause.

  20. Parts 1, 2, 3, and 4: Overall Survival (OS)

    Time frame: Up to 2 years 6 months

    The time from first dose of JNJ-63723283 to death due to any cause.

Sponsors and collaborators

Lead sponsor

Janssen Research & Development, LLC

Industry

Registry information

Official study title

63723283LUC1001: 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

Important dates

Study start
2016
Primary completion
2023
Study completion
2026
First posted
Sep 21, 2016
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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