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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05818683




Registration number
NCT05818683
Ethics application status
Date submitted
6/04/2023
Date registered
19/04/2023
Date last updated
23/05/2024

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
N/A
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
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT05818683
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
Participate-In-This-Study@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05818683