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
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ClinicalTrials.gov Identifier: NCT02908906 |
Recruitment Status
:
Recruiting
First Posted
: September 21, 2016
Last Update Posted
: April 25, 2018
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Condition or disease | Intervention/treatment | Phase |
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Neoplasms | Drug: JNJ-63723283 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 229 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | November 21, 2016 |
Estimated Primary Completion Date : | April 30, 2019 |
Estimated Study Completion Date : | December 4, 2019 |
Arm | Intervention/treatment |
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Experimental: JNJ-63723283
In Part 1, the first cohort will receive JNJ-63723283 at a starting dose of 80 milligram (mg), intravenously (IV) every 2 weeks. JNJ-63723283 doses will be escalated following a modified Continual Reassessment Method (mCRM). Multiple doses and schedules may be explored. In Part 2, participants will receive JNJ-63723283 at the recommended Phase 2 dose (RP2D) determined in Part 1.
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Drug: JNJ-63723283
JNJ-63723283 administered by IV infusion.
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- Frequency and Severity of Dose-Limiting Toxicity (DLT) [ Time Frame: Approximate 2.5 years ]
- Overall Response Rate (ORR) per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Subjects With Selected Advanced Solid Tumors [ Time Frame: Approximate 2.5 years ]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.
- Number of Participants With Adverse Events as a Measure of Safety [ Time Frame: Approximate 2.5 years ]
- Maximum Observed Serum Concentration (Cmax) [ Time Frame: Approximate 2.5 years ]The Cmax is the maximum observed serum concentration.
- Area Under the Concentration-Time Curve Between t1 and t2 (AUCt1-t2) [ Time Frame: Approximate 2.5 years ]
- Elimination Half-Life (t1/2) [ Time Frame: Approximate 2.5 years ]The elimination half-life (t1/2) is the time measured for the serum concentration to decrease by 1 half to its original concentration.
- Total Systemic Clearance of (CL) [ Time Frame: Approximate 2.5 years ]Systemic Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body.
- Volume of Distribution at Steady-State (Vss) [ Time Frame: Approximate 2.5 years ]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.
- Accumulation Ratio (R) [ Time Frame: Approximate 2.5 years ]The R is obtained by dividing AUC at two different time points.
- Presence of Anti-JNJ-63723283 Antibodies and Effect on Serum JNJ-63723283 Concentrations [ Time Frame: Approximate 2.5 years ]Serum samples will be screened for antibodies binding to JNJ-63723283. The titer of confirmed positive samples will be reported.
- Overall Response Rate (ORR) per Immune-Related Response Criteria (irRC) [ Time Frame: Approximate 2.5 years ]ORR is defined as percentage of subjects with best objective response of complete response (CR) or partial response (PR) based on irRC criteria.
- Duration of Response (DOR) per RECIST v1.1 [ Time Frame: Approximate 2.5 years ]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.
- Duration of Response (DOR) per irRC [ Time Frame: Approximate 2.5 years ]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.
- Progression-free Survival (PFS) per RECIST v1.1 [ Time Frame: Approximate 2.5 years ]The time from first dose of JNJ-63723283 to progressive disease as defined by RECIST v 1.1 or death due to any cause.
- Progression-free Survival (PFS) per irRC [ Time Frame: Approximate 2.5 years ]The time from first dose of JNJ-63723283 to progressive disease as defined by irRC or death due to any cause.
- Overall Survival (OS) [ Time Frame: Approximate 2.5 years ]The time from first dose of JNJ-63723283 to death due to any cause.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have an Eastern Cooperative Oncology Group [ECOG] performance status 0 or 1
- Has thyroid function laboratory values within normal range
- Women of childbearing potential must have a negative serum pregnancy test
- Willing and able to adhere to the prohibitions and restrictions specified in this protocol
- 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
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 halflives, 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 woman 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908906
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: | JNJ.CT@sylogent.com |
United States, Missouri | |
Washington University School of Medicine | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
United States, Pennsylvania | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Italy | |
Ospedali Riuniti Di Ancona | Recruiting |
Ancona, Italy, 60126 | |
Ospedale San Giuseppe Moscati di Avellino | Withdrawn |
Avellino, Italy, 83100 | |
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Recruiting |
Meldola, Italy, 47014 | |
Istituto Europeo di Oncologia Servizio Radioterapia | Recruiting |
Milano, Italy, 20141 | |
San Gerardo Hospital | Recruiting |
Monza, Italy, 20052 | |
IRCCS-Fondazione Pascale | Recruiting |
Napoli, Italy, 80131 | |
Aou San Luigi Gonzaga | Recruiting |
Orbassano, Italy, 10043 | |
Istituto Clinico Humanitas | Withdrawn |
Rozzano, Italy, 20089 | |
Azienda Ospedaliera Universitaria Senese | Recruiting |
Siena, Italy, 53100 | |
Poland | |
Uniwersytecki Szpital Kliniczny w Białymstoku | Recruiting |
Białystok, Poland, 15-540 | |
Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie | Recruiting |
Warszawa, Poland, 02-781 | |
Russian Federation | |
FSBSI 'N. N. Blokhin Russian Cancer Research Center' | Recruiting |
Moscow, Russian Federation, 115478 | |
Pyatigorsky Oncology Dispensary | Recruiting |
Pyatigorsk, Russian Federation, 357502 | |
BioEk, LLC | Recruiting |
St. Petersburg, Russian Federation, 197342 | |
City Oncology Dispensary | Recruiting |
St. Petersburg, Russian Federation, 198255 | |
Spain | |
Hosp. Univ. Germans Trias I Pujol | Completed |
Badalona, Spain, 8916 | |
Hosp. Univ. Vall D Hebron | Recruiting |
Barcelona, Spain, 8035 | |
Hosp. Gral. Univ. Gregorio Maranon | Recruiting |
Madrid, Spain, 28009 | |
Hosp. Univ. Fund. Jimenez Diaz | Recruiting |
Madrid, Spain, 28040 | |
Hosp. Univ. 12 de Octubre | Recruiting |
Madrid, Spain, 28041 | |
Hosp. Univ. Hm Sanchinarro | Recruiting |
Madrid, Spain, 28050 | |
Hosp. Virgen de La Victoria | Recruiting |
Malaga, Spain, 29010 | |
Clinica Univ. de Navarra | Recruiting |
Pamplona, Spain, 31008 | |
Hosp. Virgen Del Rocio | Recruiting |
Sevilla, Spain, 41013 | |
Hosp. Clinico Univ. de Valencia | Recruiting |
Valencia, Spain, 46010 | |
United Kingdom | |
Beatson West Of Scotland Cancer Centre | Recruiting |
Glasgow, United Kingdom, G12 0YN | |
Sarah Cannon Research Institute | Recruiting |
London, United Kingdom, W1G 6AD | |
The Christie Nhs Foundation Trust | Recruiting |
Manchester, United Kingdom, M20 4BX | |
Sir Bobby Robson Unit, Northern Centre for Cancer Care | Recruiting |
Newcastle Upon Tyne, United Kingdom, NE7 7DN |
Study Director: | Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC |
Additional Information:
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT02908906 History of Changes |
Other Study ID Numbers: |
CR108223 2016-002017-22 ( EudraCT Number ) 63723283LUC1001 ( Other Identifier: Janssen Research & Development, LLC ) |
First Posted: | September 21, 2016 Key Record Dates |
Last Update Posted: | April 25, 2018 |
Last Verified: | April 2018 |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Antibodies Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |