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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02829099
Registration number
NCT02829099
Ethics application status
Date submitted
7/07/2016
Date registered
12/07/2016
Date last updated
6/10/2022
Titles & IDs
Public title
A Study of Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107 in Participants With Advanced Stage Tumors
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Scientific title
A Phase 1, Open-Label Study of the Safety, Pharmacokinetics and Pharmacodynamics of JNJ-64457107, an Agonistic Human Monoclonal Antibody Targeting CD40 in Patients With Advanced Stage Solid Tumors
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Secondary ID [1]
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64457107CAN1001
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Secondary ID [2]
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CR108186
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Neoplasms
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-64457107
Experimental: JNJ-64457107 - In Part 1, the first cohort will receive JNJ-64457107 at a starting dose of 75 microgram per kilogram (mcg/kg). The proposed treatment schedule is intravenous (IV) dosing every 14 days. JNJ-64457107 doses will be escalated following a modified Continual Reassessment Method (mCRM); the JNJ-64457107 dose will be increased by not more than half-logarithmical (3.2-fold) dose increments. Dose escalation will continue until the maximum tolerated dose (MTD) and/or RP2D of JNJ-64457107 are defined or the maximum-administered dose (MAD) has been reached. In Part 2, subjects will receive JNJ-64457107 at the RP2D and regimen determined in Part 1.
Treatment: Drugs: JNJ-64457107
JNJ-64457107 administered by IV infusion on Day 1 and 14 of a 28-day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose-limiting toxicities (Part 1)
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Assessment method [1]
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Dose-limiting toxicities will be reviewed as a subset of adverse events that occur within the first 28 days of dosing and meet protocol-specified criteria.
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Timepoint [1]
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Up to 28 days
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Primary outcome [2]
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Incidence of adverse events (Part 1 and 2)
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Assessment method [2]
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Timepoint [2]
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From signing of informed consent form (ICF) until 30 days after last dose of study drug (approximately up to 29 Months)
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Secondary outcome [1]
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Overall response rate (ORR)
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Assessment method [1]
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The ORR is the proportion of participants with confirmed best objective response of complete response (CR) or immune-related CR (irCR).
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Timepoint [1]
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Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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For participants who achieve CR or partial response (PR), DOR will be calculated as time from initial response of CR or PR to progressive disease or death due to underlying disease, whichever comes first.
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Timepoint [2]
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Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
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Secondary outcome [3]
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Progression-free Survival (PFS)
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Assessment method [3]
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PFS is defined as the time from first dose of JNJ-64457107 to progressive disease or death due to any cause, whichever occurs first.
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Timepoint [3]
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Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall survival is defined as the time from first dose of JNJ-64457107 to date of death from any cause.
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Timepoint [4]
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Disease assessment will continue until progression or lost to follow-up (approximately up to 29 months)
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Secondary outcome [5]
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Maximum observed serum concentration (Cmax) of JNJ-64457107
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Assessment method [5]
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Timepoint [5]
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Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
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Secondary outcome [6]
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Time of maximum observed serum concentration (Tmax) of JNJ-64457107
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Assessment method [6]
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The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
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Timepoint [6]
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Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
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Secondary outcome [7]
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Area under the serum concentration versus time curve from time 0 to infinity (AUCinf) of JNJ-64457107
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Assessment method [7]
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The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
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Timepoint [7]
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Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
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Secondary outcome [8]
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Area under the serum concentration versus time curve from time 0 to the final quantifiable time point (t) [AUC(0-t)] of JNJ-64457107
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Assessment method [8]
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Timepoint [8]
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Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
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Secondary outcome [9]
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Area under the serum concentration versus time curve during a dosing interval (AUCtau) of JNJ-64457107
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Assessment method [9]
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Timepoint [9]
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Cycle 1 Day 1 and Cycle 2 Day 15: predose, 1, 4, 24, 48, 72 hours post end of infusion (EOI); any time (Cycle 1 Day 8 and Cycle 2 Day 22); predose (Cycle 1 Day 15 and Cycle 3 and 4); end of treatment
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Secondary outcome [10]
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Immunogenicity of JNJ-64457107 when administered IV
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Assessment method [10]
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Detection and characterization of antibodies to JNJ-64457107
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Timepoint [10]
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Cycle 1: predose on Day 1; Cycle 2: predose on Day 1; Cycles 3, 4: predose; end of treatment visit
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Eligibility
Key inclusion criteria
* Part 1: advanced stage solid tumors; Part 2: non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma
* Eastern cooperative oncology group (ECOG) performance score of 0 or 1
* Adequate organ function as defined in the protocol
* A woman of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin [beta-hCG]) pregnancy test at Screening and a negative urine pregnancy test prior to the first dose of study drug
* During the study and for at least 120 days after receiving the last dose of study drug, in addition to the highly effective method of contraception, a man who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (example [eg.], condom with spermicidal foam/gel/film/cream/suppository), or who is sexually active with a woman who is pregnant must use a condom
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Malignancy other than the disease under study within 2 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence)
* Symptomatic brain metastases; asymptomatic brain metastases are allowed provided that they have been treated, have been stable for greater than (>) 6 weeks as documented by radiographic imaging, and do not require prolonged (>14 days) systemic corticosteroid therapy
* Treatment with any local or systemic anti-neoplastic therapy 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
* Toxicities from previous anti-cancer therapies have not resolved to baseline levels or to Grade 1 or less except for alopecia and peripheral neuropathy
* Major surgery (eg., requiring general anesthesia) within 3 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/09/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/07/2021
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Sample size
Target
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Accrual to date
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Final
95
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Israel
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State/province [1]
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Haifa
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Country [2]
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Israel
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State/province [2]
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Jerusalem
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Country [3]
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Israel
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State/province [3]
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Tel Aviv
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary purpose of the study is to determine the recommended Phase 2 dose (RP2D) and schedule of JNJ-64457107 when administered intravenously (IV) to participants with advanced stage solid tumors in Part 1 and to further characterize the safety of JNJ-64457107 when administered IV to participants with non-small cell lung cancer (NSCLC), pancreatic cancer and cutaneous melanoma in Part 2.
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Trial website
https://clinicaltrials.gov/study/NCT02829099
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02829099
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