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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
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
Secondary ID [1] 0 0
78278343PCR1003
Secondary ID [2] 0 0
CR109321
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration-resistant Prostate Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to 21 days after first dose of combination agent
Primary outcome [2] 0 0
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
Timepoint [2] 0 0
Up to 2 years 11 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR)
Timepoint [1] 0 0
Up to 2 years 11 months
Secondary outcome [2] 0 0
Prostate Specific Antigen (PSA) Response Rate
Timepoint [2] 0 0
Up to 2 years 11 months
Secondary outcome [3] 0 0
Radiographic Progression-free Survival (rPFS)
Timepoint [3] 0 0
Up to 2 years 11 months
Secondary outcome [4] 0 0
Time to Response (TTR)
Timepoint [4] 0 0
Up to 2 years 11 months
Secondary outcome [5] 0 0
Duration of Response (DOR)
Timepoint [5] 0 0
Up to 2 years 11 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
345
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Macquarie University - Macquarie University
Recruitment hospital [2] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
3000 - Melbourne
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Michigan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
844-434-4210
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.janssen.com/clinical-trials/transparency


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