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Metastatic Castration-resistant Prostate NeoplasmsPhase 1NCT05818683

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

A Phase 1 study testing Pasritamig, Cetrelimab and Cabazitaxel in people with Metastatic Castration-resistant Prostate Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, run by Janssen Research & Development, LLC at 15 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Pasritamig, Cetrelimab and Cabazitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
15 sitesin 3 countries
Study dates
26 Apr 2023to 23 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone [AAP], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram [ng]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)
  • Measurable or evaluable disease, except for Part 2H
  • (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K \& 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ functions

Who cannot join

  • 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 pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \& 2K)
  • Significant infections or serious lung, heart or other medical conditions

Trial locations and contacts

15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

15 sites in 3 countries

United States7 sites, 7 recruiting

  • Perlmutter Cancer Center at NYU Langone Brooklyn

    Brooklyn, Mississippi, 11223

    Recruiting

  • Start Midwest

    Grand Rapids, Michigan, 49546

    Recruiting

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island

    Mineola, New York, 11501

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    Recruiting

  • Sidney Kimmel Cancer Center - Jefferson Health

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Recruiting

  • Washington University School Of Medicine

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Icon Cancer Centre Kurralta Park

    Adelaide, 5037

    Recruiting

  • Macquarie University

    Macquarie Park, 2109

    Recruiting

  • Peter MacCallum Cancer Centre

    Melbourne, 3000

    Recruiting

  • Princess Alexandra Hospital

    Woolloongabba, 4102

    Recruiting

Other trials in Australia

Spain4 sites, 4 recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

    Recruiting

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

    Recruiting

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

    Recruiting

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

    Recruiting

Other trials in Spain

About this study

Official title: A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Being tested
Pasritamig, Cetrelimab, Cabazitaxel, Docetaxel, Apalutamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PasritamigDrug

    Also called JNJ-78278343

    Pasritamig will be administered.

  • CetrelimabDrug

    Also called JNJ-63723283

    Cetrelimab will be administered by intravenous infusion.

  • CabazitaxelDrug

    Cabazitaxel will be administered by intravenous infusion.

  • DocetaxelDrug

    Docetaxel will be administered by intravenous infusion.

  • ApalutamideDrug

    Apalutamide will be administered orally.

  • EnzalutamideDrug

    Enzalutamide will be administered orally.

  • DarolutamideDrug

    Darolutamide will be administered orally.

  • Abiraterone acetate plus prednisone (AAP)Drug

    Abiraterone acetate plus prednisone (AAP) will be administered orally.

  • Lutetium Lu-177 vipivotide tetraxetanDrug

    Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.

  • JNJ-101556143Drug

    JNJ-101556143 will be administered orally.

Study groups in NCT05818683
Study groupRoleWhat they receive
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion)ExperimentalParticipants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
Receives: Drug: Pasritamig; Drug: Cetrelimab; Drug: Cabazitaxel; Drug: Docetaxel; Drug: Apalutamide; Drug: Enzalutamide; Drug: Darolutamide; Drug: Abiraterone acetate plus prednisone (AAP); Drug: Lutetium Lu-177 vipivotide tetraxetan; Drug: JNJ-101556143

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants With Dose Limiting Toxicity (DLT)

    DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.

    Measured: Up to 21 days after first dose of combination agent

  2. Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity

    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.

    Measured: Up to 2 years 11 months

Secondary outcomes (6)

  1. Overall Response Rate (ORR)

    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.

    Measured: Up to 2 years 11 months

  2. Prostate Specific Antigen (PSA) Response Rate

    PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.

    Measured: Up to 2 years 11 months

  3. Radiographic Progression-free Survival (rPFS)

    rPFS is defined time from the date of first dose of pasritamig until the date of objective disease progression or death, whichever comes first.

    Measured: Up to 2 years 11 months

  4. Time to Response (TTR)

    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.

    Measured: Up to 2 years 11 months

  5. Duration of Response (DOR)

    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.

    Measured: Up to 2 years 11 months

  6. Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS)

    Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors [RECIST] or bone progression), pain, PSA progression, death or last disease assessment.

    Measured: Up to 2 years 11 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2023
  2. Study start26 Apr 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion23 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05818683
Sponsor's protocol ID
CR109321
Other IDs
78278343PCR1003, 2022-503132-14-00
Status last verified
Nov 2026
First submitted
6 Apr 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pasritamig, Cetrelimab and Cabazitaxel in people with Metastatic Castration-resistant Prostate Neoplasms and Metastatic Hormone-sensitive Prostate Cancer, run by Janssen Research & Development, LLC at 15 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Australia, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Up to 21 days after first dose of combination agent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05818683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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