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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05818683
Registration number
NCT05818683
Ethics application status
Date submitted
6/04/2023
Date registered
19/04/2023
Titles & IDs
Public title
A Study of JNJ-78278343 in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer
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Scientific title
A Phase 1b Study of JNJ-78278343, a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With Either JNJ-63723283 (Cetrelimab), Taxane Chemotherapy, or Androgen Receptor Pathway Inhibitors for Metastatic Castration-Resistant Prostate Cancer
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Secondary ID [1]
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78278343PCR1003
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Secondary ID [2]
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CR109321
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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:
Metastatic Castration-resistant Prostate Neoplasms
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - JNJ-78278343
Treatment: Drugs - Cetrelimab
Treatment: Drugs - Cabazitaxel
Treatment: Drugs - Docetaxel
Treatment: Drugs - Apalutamide
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Darolutamide
Treatment: Drugs - Abiraterone acetate plus prednisone (AAP)
Experimental: JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) - Participants will receive JNJ-78278343 and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone) during Part 1 (dose escalation). The dose of JNJ-78278343 will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive JNJ-78278343 and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
Treatment: Drugs: JNJ-78278343
JNJ-78278343 will be administered.
Treatment: Drugs: Cetrelimab
Cetrelimab will be administered by intravenous infusion.
Treatment: Drugs: Cabazitaxel
Cabazitaxel will be administered by intravenous infusion.
Treatment: Drugs: Docetaxel
Docetaxel will be administered by intravenous infusion.
Treatment: Drugs: Apalutamide
Apalutamide will be administered orally.
Treatment: Drugs: Enzalutamide
Enzalutamide will be administered orally.
Treatment: Drugs: Darolutamide
Darolutamide will be administered orally.
Treatment: Drugs: Abiraterone acetate plus prednisone (AAP)
Abiraterone acetate plus prednisone (AAP) will be administered orally.
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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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Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
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Assessment method [1]
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DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
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Timepoint [1]
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Up to 21 days after first dose of combination agent
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Primary outcome [2]
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Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
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Timepoint [2]
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Up to 2 years 11 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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ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
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Timepoint [1]
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Up to 2 years 11 months
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Secondary outcome [2]
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Prostate Specific Antigen (PSA) Response Rate
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Assessment method [2]
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PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
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Timepoint [2]
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Up to 2 years 11 months
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Secondary outcome [3]
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Radiographic Progression-free Survival (rPFS)
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Assessment method [3]
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rPFS is defined time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.
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Timepoint [3]
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Up to 2 years 11 months
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Secondary outcome [4]
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Time to Response (TTR)
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Assessment method [4]
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TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed.
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Timepoint [4]
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Up to 2 years 11 months
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Secondary outcome [5]
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Duration of Response (DOR)
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Assessment method [5]
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DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.
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Timepoint [5]
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Up to 2 years 11 months
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Eligibility
Key inclusion criteria
* Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by Prostate Cancer Working Group 3 (PCWG3)
* Measurable or evaluable disease.
* (a) Part 1A: JNJ-78278343 + cetrelimab - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (eg, docetaxel). (b) Part 1C: JNJ-78278343 + docetaxel, Part 1D: JNJ-78278343 + apalutamide, Part 1E: JNJ-78278343 + enzalutamide, Part 1F: JNJ-78278343 + darolutamide, and Part 1G: JNJ-78278343 + abiraterone acetate + prednisone - Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate,). (C) Part 1B: JNJ-78278343 + cabazitaxel - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ functions
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (<=) 1 or baseline levels (except for alopecia, vitiligo, Grade <=2 peripheral neuropathy)
* Solid organ or bone marrow transplantation
* Known allergies, or intolerance to any of the components (example, excipients) of JNJ-78278343, cetrelimab (Part 1A), cabazitaxel, (Part 1B), docetaxel (Part 1C), apalutamide (Part 1D), enzalutamide (Part 1E), darolutamide (Part 1F), or abiraterone acetate + prednisone (AAP) (Part 1G)
* Significant infections or serious lung, heart or other medical conditions
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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
Other
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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
Recruiting
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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
26/04/2023
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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
1/09/2027
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Actual
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Sample size
Target
345
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Macquarie University - Macquarie University
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [3]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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2109 - Macquarie University
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment postcode(s) [3]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Florida
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Country [2]
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United States of America
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State/province [2]
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Michigan
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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 purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of JNJ-78278343 and combination agent in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of JNJ-78278343 with the combination agent in Part 2 (dose expansion).
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Trial website
https://clinicaltrials.gov/study/NCT05818683
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Trial related presentations / publications
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Public notes
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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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Study Contact
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Address
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Country
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Phone
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844-434-4210
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency
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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/NCT05818683