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Prostatic NeoplasmsPhase 1NCT04898634

A Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

A Phase 1 study testing JNJ-78278343 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 17 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion). Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
JNJ-78278343
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
17 sitesin 6 countries
Study dates
13 Jul 2021to 31 Dec 2027
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

  • Confirmed adenocarcinoma of the prostate which has spread to other body parts
  • Part 1: Prior treatment with at least 1 prior novel androgen receptor (AR)-targeted therapy or chemotherapy
  • Measurable or evaluable disease
  • Concurrent use of any other anticancer treatment must be discontinued for at least 2 weeks before the first dose of study drug
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Prior surgical removal of testicles; or, for participants who have not undergone surgical removal of testicles, must be receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog

Who cannot join

  • Disease conditions
  • Active central nervous system (CNS) involvement
  • Toxicity related to prior anticancer therapy has not adequately recovered
  • Prior/Concomitant Therapy
  • Prior treatment with human kallikrein (KLK) 2-targeted therapy
  • Received, or are receiving, medications that suppress the immune system within 3 days prior to the first dose of study drug
Show all 18Show fewer
  • Received or plans to receive any live, attenuated vaccine within 4 weeks prior to the first dose of study drug
  • Prior/Concurrent Medical Conditions
  • Diagnosis of cancer other than prostate cancer within 2 years prior to the first dose of study drug
  • Solid organ or bone marrow transplantation
  • Major clotting diseases within one month prior to the first dose of study drug
  • Active autoimmune disease within 12 months prior to the first dose of study drug
  • Active infection
  • Major diseases of heart and blood vessels within 6 months prior to the first dose of study drug
  • Clinically significant lung diseases
  • Active or chronic hepatitis B or hepatitis C infection
  • Known positive test result for human immunodeficiency virus (unless stable on antiretroviral therapy with undetectable viral load)
  • Any serious underlying medical conditions or other issue that would impair the ability of the participant to receive or tolerate the planned treatment

Trial locations and contacts

17 sites in 6 countries.

17 sites in 6 countries

China4 sites

  • Peking University Third Hospital

    Beijing, 100191

  • Chongqing University Cancer Hospital

    Chongqing, 400030

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510710

  • First Affiliated Hospital Of Wenzhou Medical College

    Wenzhou, 325399

Other trials in China

United States3 sites

  • Columbia University Medical Center Herbert Irving Pavilion

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Washington

    Seattle, Washington, 98195-9472

Other trials in United States

France3 sites

  • Centre Leon Berard

    Lyon, 69373

  • APHM Hopital Timone

    Marseille, 13005

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

Spain3 sites

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040

  • Hosp Univ Hm Sanchinarro

    Madrid, 28050

  • Hosp Virgen de La Victoria

    Málaga, 29010

Other trials in Spain

Japan2 sites

  • National Cancer Center Hospital East

    Kashiwa, 277 8577

  • Yokohama City University Medical Center

    Yokohama, 232 0024

Other trials in Japan

Netherlands2 sites

  • Antoni van Leeuwenhoek

    Amsterdam, 1066 CX

  • Erasmus MC

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: A Phase 1 Study of JNJ-78278343, a T-Cell-Redirecting Agent Targeting Human Kallikrein 2 (KLK2), for Advanced Prostate Cancer

The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).

Being tested
JNJ-78278343
Keywords
Metastatic castration-resistant prostate cancer (mCRPC), Advanced prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • JNJ-78278343Drug

    JNJ-78278343 will be administered.

Study groups in NCT04898634
Study groupRoleWhat they receive
JNJ-78278343ExperimentalParticipants will receive JNJ-78278343. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by the study evaluation team (SET) in Part 1 (dose escalation). In Part 2 (dose expansion), participants will receive JNJ-78278343 at recommended phase 2 dose (RP2D) as determined in Part 1. Participants who are still on study treatment (i.e., who are in Treatment Phase) at the time of the long term extension (LTE) will continue to receive study treatment until they reach a reason for discontinuation of treatment or until further notification by the sponsor of a different means for continued supply of study treatment, whichever occurs first.
Receives: Drug: JNJ-78278343

What is being measured

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

  1. Part 1 and 2: Number of Participants With Adverse Events (AEs)

    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.

    Measured: Up to 1 year and 10 months

  2. Part 1 and 2: Number of Participants With AEs by Severity

    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.

    Measured: Up to 1 year and 10 months

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

    Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.

    Measured: Up to 1 year and 10 months

Secondary outcomes (8)

  1. Serum Concentration of JNJ-78278343

    Serum concentrations of JNJ-78278343 will be determined.

    Measured: Up to 1 year and 10 months

  2. Systemic Cytokine Concentrations

    Cytokine concentrations will be determined for biomarker assessment.

    Measured: Up to 1 year and 10 months

  3. Serum Prostate Specific Antigen (PSA) Concentration

    Serum PSA concentration will be measured.

    Measured: Up to 1 year and 10 months

  4. Number of Participants With Anti-JNJ-78278343 Antibodies

    Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.

    Measured: Up to 1 year and 10 months

  5. 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 and 10 months

  6. Radiographic Progression-free Survival (rPFS)

    rPFS is defined as time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.

    Measured: Up to 1 year and 10 months

  7. PSA Response Rate

    PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment.

    Measured: Up to 1 year and 10 months

  8. 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 and 10 months

Timeline

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

  1. First posted24 May 2021
  2. Study start13 Jul 2021
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (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
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04898634
Sponsor's protocol ID
CR108958
Other IDs
78278343PCR1001, 2020-005970-83, 2023-506585-31-00, 2023
Status last verified
Nov 2026
First submitted
20 May 2021
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.

Publications

  • Stein MN, Vinceneux A, Robbrecht D, Doger B, Autio KA, Schweizer MT, Calvo E, Medina L, Van Dongen M, Deville JL, Bernard-Tessier A, Ghosh D, Shotts K, Shen F, Jaiprasart P, Chaudhary R, Wu S, Cartee L, Schnepp R, Gaut D, Lauring J, Wang SC, Villalobos VM, Baldini C. Pasritamig, a First-in-Class, Bispecific T-Cell Engager Targeting Human Kallikrein 2, in Metastatic Castration-Resistant Prostate Cancer: A Phase I Study. J Clin Oncol. 2025 Aug;43(22):2515-2526. doi: 10.1200/JCO-25-00678. Epub 2025 Jun 1.

    PubMed 40450573

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JNJ-78278343 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 17 sites in 6 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 18 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: under way, not looking for participants, 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 17 sites in China, United States, France, Spain, Japan and 1 more country. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 and 2: Number of Participants With Adverse Events (AEs) (time frame: Up to 1 year and 10 months). The study lists 3 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 NCT04898634, which also lists 1 linked publication.

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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