Prostatic NeoplasmsPhase 1NCT06095089
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
A Phase 1 study testing JNJ-78278343, JNJ-87189401 and Apalutamide in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 22 sites in 5 countries.
Trial summary
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. 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, JNJ-87189401 and Apalutamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 1 Nov 2023to 28 Jun 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
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Who cannot join
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Trial locations and contacts
22 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
22 sites in 5 countries
United States13 sites, 13 recruiting
- Recruiting
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
- Recruiting
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
START New Jersey
East Brunswick, New Jersey, 08816
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
University Of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
Tennessee Oncology
Nashville, Tennessee, 37203
- Recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
New York, New York, 10032
- Recruiting
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
- Recruiting
Oregon Health And Science University
Portland, Oregon, 97239
- Recruiting
South Texas Accelerated Research Therapeutics, LLC (START)
San Antonio, Texas, 78229
- Recruiting
Swedish Medical Center
Seattle, Washington, 98104
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
China3 sites, 3 recruiting
- Recruiting
Chongqing University Cancer Hospital
Chongqing, 400030
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
- Recruiting
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710004
France3 sites, 3 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33000
- Recruiting
Centre Leon Berard
Lyon, 69008
- Recruiting
Institut Gustave Roussy
Villejuif, 94800
Australia2 sites, 2 recruiting
- Recruiting
Greenslopes Private Hospital
Greenslopes, 4120
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, 3000
Japan1 site, 1 recruiting
- Recruiting
The Cancer Institute Hospital of JFCR
Tokyo, 135 8550
About this study
Official title: A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- JNJ-78278343, JNJ-87189401, Apalutamide, Lutetium Lu-177 Vipivotide Tetraxetan, JNJ-101556143
- 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
Also called KLK2-CD3, Pasritamig
JNJ-78278343 will be administered.
JNJ-87189401Drug
Also called PSMAxCD28
JNJ-87189401 will be administered.
ApalutamideDrug
Apalutamide will be administered.
Lutetium Lu-177 Vipivotide TetraxetanDrug
Lutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment.
JNJ-101556143Drug
Also called HLD-0915
JNJ-101556143 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). Receives: Drug: JNJ-78278343; Drug: JNJ-87189401 |
| Part 2 (Dose Expansion) | Experimental | Participants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. Receives: Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: Apalutamide |
| Part 3 | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. Receives: Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: Lutetium Lu-177 Vipivotide Tetraxetan |
| Part 4 | Experimental | Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. Receives: Drug: JNJ-78278343; Drug: JNJ-87189401; Drug: JNJ-101556143 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Measured: Up to 21 days after first combination dose of study drugs
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 4 years 8 months
Secondary outcomes (7)
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Serum samples will be analyzed to determine concentrations of JNJ-87189401 and JNJ-78278343.
Measured: Up to 4 years 8 months
Plasma Concentration of JNJ-101556143
Plasma samples will be analyzed to determine concentrations of JNJ-101556143.
Measured: Up to 4 years 8 months
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Number of participants with antibodies to JNJ-87189401 and JNJ-78278343 will be reported.
Measured: Up to 4 years 8 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a partial response (PR) or better according to response evaluation criteria in solid tumors (RECIST) version 1.1 without evidence of bone progression according to Prostate Cancer Clinical Trials Working Group 3 (PCWG3).
Measured: Up to 4 years 8 months
Radiographic Progression-Free Survival (rPFS)
rPFS is defined time from the date of first dose of study drug until the date of objective disease progression or death, whichever comes first.
Measured: Up to 4 years 8 months
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 4 years 8 months
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 4 years 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Nov 2023
- Primary completion21 Jun 2027 (estimated)
- Study completion28 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06095089
- Sponsor's protocol ID
- CR109330
- Other IDs
- 87189401PCR1001, 2023-504063-17-00, 2023
- Status last verified
- Nov 2026
- First submitted
- 18 Oct 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JNJ-87189401 (PSMA-CD28 Bispecific Antibody) Combined With JNJ-78278343 (KLK2-CD3 Bispecific Antibody) for Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT06095089
- Acronym / sponsor ID
- CR109330
- Conditions
- Prostatic Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 21 Jun 2027 (estimated)
- Study completion
- 28 Jun 2028 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of Parts 1, 2A, and 2B of the study is to determine the recommended regimen for Phase 2 (RP2Rs) of combination of JNJ-87189401 with JNJ-78278343 and the purpose of Part 2C of this study is to determine how safe the RP2R(s) of the combination of JNJ-87189401 and JNJ-78278343 is, with or without apalutamide. Part 3 of this study evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with standard of care (SOC) lutetium Lu-177 vipivotide tetraxetan. Part 4 of this study further evaluates the safety of the triplet combination of JNJ-87189401 and JNJ-78278343 with JNJ-101556143 in participants with advanced prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1 (Dose Escalation) | Experimental | Drug: JNJ-78278343, Drug: JNJ-87189401Participants will receive JNJ-78278343 + JNJ-87189401 escalated sequentially in Part 1 to select a recommended Phase 2 regimen (RP2R). |
| Part 2 (Dose Expansion) | Experimental | Drug: JNJ-78278343, Drug: JNJ-87189401, Drug: ApalutamideParticipants with different disease settings in Parts 2A and 2B will receive JNJ-78278343+JNJ-87189401 at the RP2R selected in Part 1. Participants in Part 2C will receive apalutamide plus continued treatment with JNJ-87189401+JNJ-78278343 doublet. |
| Part 3 | Experimental | Drug: JNJ-78278343, Drug: JNJ-87189401, Drug: Lutetium Lu-177 Vipivotide TetraxetanParticipants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) selected in Part 1 along with standard of care (SOC) treatment with lutetium Lu-177 vipivotide tetraxetan. Dosing of JNJ-78278343+JNJ-87189401 will be escalated sequentially, as per study evaluation team (SET) decision. |
| Part 4 | Experimental | Drug: JNJ-78278343, Drug: JNJ-87189401, Drug: JNJ-101556143Participants will receive JNJ-78278343 + JNJ-87189401 at one or more RP2R (s) along with JNJ-101556143. Dosing of JNJ-78278343+JNJ-87189401 along with JNJ-101556143 will be escalated sequentially to determine the RP2R of the combinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed adenocarcinoma of the prostate. Adenocarcinoma with small cell or neuroendocrine (NE) features is permitted. However, small cell carcinoma, carcinoid tumor, mixed NE carcinoma, or large cell NE carcinoma is disallowed
- Measurable or evaluable disease per PCWG3 criteria
- Part 1, Parts 2A, 2B, 3 and 4: Prior orchiectomy or medical castration; participants who have not undergone orchiectomy, 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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Key exclusion criteria (2 listed)
- History of an autoimmune disease within the 12 months prior to signing consent
- Any of the following within 6 months prior to signature of informed consent: a. myocardial infarction, b. severe or unstable angina, c. clinically significant ventricular arrhythmias, d. congestive heart failure (New York Heart Association [NYHA] class II to IV), e. transient ischemic attack, and f. Cerebrovascular accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-78278343Also: KLK2-CD3, PasritamigJNJ-78278343 will be administered. | Drug | Part 1 (Dose Escalation), Part 2 (Dose Expansion), Part 3, Part 4 |
| JNJ-87189401Also: PSMAxCD28JNJ-87189401 will be administered. | Drug | Part 1 (Dose Escalation), Part 2 (Dose Expansion), Part 3, Part 4 |
| ApalutamideApalutamide will be administered. | Drug | Part 2 (Dose Expansion) |
| Lutetium Lu-177 Vipivotide TetraxetanLutetium Lu-177 Vipivotide Tetraxetan will be administered as SOC treatment. | Drug | Part 3 |
| JNJ-101556143Also: HLD-0915JNJ-101556143 will be administered. | Drug | Part 4 |
Primary outcome
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 21 days after first combination dose of study drugs
DLTs are specific adverse events (AEs) and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Number of Participants with Adverse Events (AEs) by Severity
Time frame: Up to 4 years 8 months
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.
7 secondary outcomes
Serum Concentrations of JNJ-87189401 and JNJ-78278343
Time frame: Up to 4 years 8 months
Plasma Concentration of JNJ-101556143
Time frame: Up to 4 years 8 months
Number of Participants With Antibodies to JNJ-87189401 and JNJ-78278343
Time frame: Up to 4 years 8 months
Objective Response Rate (ORR)
Time frame: Up to 4 years 8 months
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 4 years 8 months
Prostate Specific Antigen (PSA) Response Rate
Time frame: Up to 4 years 8 months
Duration of Response (DOR)
Time frame: Up to 4 years 8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-78278343, JNJ-87189401 and Apalutamide in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 22 sites in 5 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 4 inclusion and 2 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 22 sites in United States, China, France, Australia, Japan. 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?
Parts 1, 2C, 3 and 4: Number of Participants With Dose Limiting Toxicity (DLT) (time frame: Up to 21 days after first combination dose of study drugs). 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?
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; AzTrials last refreshed its copy on 8 Nov 2026.