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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02908906|
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Neoplasms||Drug: JNJ-63723283||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||229 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
JNJ-63723283 administered by IV infusion.
- 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.
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|
|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|
|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|
|Uniwersytecki Szpital Kliniczny w Białymstoku||Recruiting|
|Białystok, Poland, 15-540|
|Centrum Onkologii-Instytut im. Marii Skłodowskiej-Curie||Recruiting|
|Warszawa, Poland, 02-781|
|FSBSI 'N. N. Blokhin Russian Cancer Research Center'||Recruiting|
|Moscow, Russian Federation, 115478|
|Pyatigorsky Oncology Dispensary||Recruiting|
|Pyatigorsk, Russian Federation, 357502|
|St. Petersburg, Russian Federation, 197342|
|City Oncology Dispensary||Recruiting|
|St. Petersburg, Russian Federation, 198255|
|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|
|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|