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Prostatic NeoplasmsPhase 1NCT07319871

A Study of Pasritamig (JNJ-78278343) in Combination With JNJ-86974680 for Treatment of Prostate Cancer

A Phase 1 study testing Pasritamig and JNJ-86974680 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 5 sites in 2 countries.

Recruiting

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

Sites and contacts
Official record
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Trial summary

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Pasritamig and JNJ-86974680
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
5 sitesin 2 countries
Study dates
14 Jan 2026to 15 Mar 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed adenocarcinoma of the prostate. Primary small cell carcinoma, carcinoid tumor, neuroendocrine (NE) carcinoma, or large cell NE carcinoma arising in the prostate are not allowed; however, adenocarcinomas with NE features (for example [e.g.], immunohistochemistry [IHC] with both androgen receptor [AR]- and NE-marker positivity) are allowed
  • Metastatic castration-resistant prostate cancer (mCRPC) that is metastatic either to bone, any lymph node, or both without clear evidence of metastasis to visceral organs. Local-regional invasion (rectum, bladder) and bone disease with soft tissue component can be included
  • Prior orchiectomy or medical castration (for example, must be receiving ongoing androgen deprivation therapy with a gonadotropin-releasing hormone [GnRH] analog [agonist or antagonist] prior to the first dose of study drug and must continue this therapy throughout the treatment phase)
  • Prostate-specific antigen (PSA) greater than or equal to (>=) 2 nanograms per milliliters (ng/mL) at screening
  • Measurable or evaluable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Who cannot join

  • Toxicity related to prior anticancer therapy that has not returned to grade less than or equal to (<=) 1 or baseline levels (except for alopecia, neuropathy [Grade 2] and vitiligo)
  • Known allergies, hypersensitivity, or intolerance to any of the components (for example, excipients) of pasritamig or JNJ-86974680
  • Active infection or condition that requires treatment with systemic antibiotics within 7 days prior to the first dose of study treatment. Antibiotic or antiviral prophylaxis is allowed
  • Have leptomeningeal disease or brain metastases, except participants with definitively, locally treated brain metastases that are clinically stable and asymptomatic >2 weeks, and who are off corticosteroid treatment for at least 2 weeks prior to first dose of study treatment
  • Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site to understand the informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments

Trial locations and contacts

5 sites in 2 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

5 sites in 2 countries

United States3 sites, 3 recruiting

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Recruiting

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

    Recruiting

Other trials in United States

United Kingdom2 sites, 2 recruiting

  • The Christie NHS Foundation Trust Christie Hospital

    Manchester, M20 4BX

    Recruiting

  • Royal Marsden Hospital

    Sutton, SM2 5PT

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 1b Study of Pasritamig (JNJ-78278343), a T-cell Redirecting Agent Targeting Human Kallikrein 2 (KLK2), in Combination With JNJ-86974680, an A2a Receptor (A2aR) Antagonist, for Prostate Cancer

The purpose of this study is to identify the recommended phase 2 combination dose (RP2CD) of Pasritamig in combination with JNJ-86974680 in Part 1 (Dose finding) of the study and to determine how safe and tolerable the RP2CD is for treatment of participants with advanced prostate cancer in Part 2 (Dose expansion) of study.

Being tested
Pasritamig, JNJ-86974680
Medical subject headings
Prostatic Neoplasms

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 intravenously.

  • JNJ-86974680Drug

    JNJ-86974680 will be administered orally.

Study groups in NCT07319871
Study groupRoleWhat they receive
Part 1: Dose FindingExperimentalParticipants will receive pasritamig in combination with JNJ-86974680 to determine the recommended phase 2 combination dose (RP2CD) regimen.
Receives: Drug: Pasritamig; Drug: JNJ-86974680
Part 2: Dose ExpansionExperimentalParticipants will receive pasritamig in combination with JNJ-86974680 at the RP2CD as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
Receives: Drug: Pasritamig; Drug: JNJ-86974680

What is being measured

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

  1. 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. 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. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines and ocular events will be graded using the alternative scale provided in the protocol.

    Measured: Up to 1 year 2 months

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

    High grade hematologic or non-hematologic toxicities with exceptions and/or toxicities leading to treatment discontinuation will be regarded as DLT.

    Measured: Up To Day 22

Secondary outcomes (8)

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).

    Measured: Up to 1 year 2 months

  2. Prostate-Specific Antigen (PSA) Response Rate

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

    Measured: Up to 1 year 2 months

  3. Duration of Response (DOR)

    DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.

    Measured: Up to 1 year 2 months

  4. Radiographic Progression-Free Survival (rPFS)

    rPFS is defined as the time from the date of first dose of pasritamig or JNJ-86974680 until the date of radiographic disease progression or death, whichever comes first.

    Measured: Up to 1 year 2 months

  5. Time to Response (TTR)

    TTR is defined for the responders as the time from the date of first dose of any study treatment to the date of first documented response.

    Measured: Up to 1 year 2 months

  6. Serum Concentration of Pasritamig

    Serum samples will be analyzed to determine concentrations of pasritamig.

    Measured: Up to 1 year 2 months

  7. Plasma Concentration of JNJ-86974680

    Plasma samples will be analyzed to determine concentrations of JNJ-86974680.

    Measured: Up to 1 year 2 months

  8. Number of Participants With Anti-Pasritamig Antibodies

    Serum samples will be analyzed for the detection of anti-pasritamig antibodies using a validated assay method.

    Measured: Up to 1 year 2 months

Timeline

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

  1. First posted6 Jan 2026
  2. Study start14 Jan 2026
  3. Primary completion7 Jan 2027 (estimated)
  4. Study completion15 Mar 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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319871
Sponsor's protocol ID
78278343PBPCR1005
Other IDs
78278343PBPCR1005
Status last verified
Nov 2026
First submitted
22 Dec 2025
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 www.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 and JNJ-86974680 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 5 sites in 2 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 6 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 5 sites in United States, United Kingdom. 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?

Number of Participants With Adverse Events (AEs) by Severity (time frame: Up to 1 year 2 months). 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 NCT07319871.

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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