Prostatic NeoplasmsPhase 1NCT05441501
A Study of JNJ-80038114 in Participants With Advanced Stage Prostate Cancer
A Phase 1 study testing JNJ-80038114 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 6 sites in 2 countries.
Trial summary
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) 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-80038114
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 15 Nov 2022to 31 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 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
- At least 1 prior treatment for mCRPC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions as defined by certain laboratory values
- Must sign an informed consent form (ICF)
- Participants must agree to use a highly effective form of birth control as guided by the study doctor
Who cannot join
- Concurrent anticancer therapy
- Severe or long-lasting side effects related to prior anticancer therapy
- Known allergies to JNJ-80038114 or its excipients
- Brain metastasis or known seizure history
- Significant infections or lung, heart or other medical conditions
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
University Of Minnesota
Minneapolis, Minnesota, 55455
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania, 19107
United Kingdom3 sites
University College London Hospitals NHSFT
London, NW1 2PG
The Christie NHS Foundation Trust Christie Hospital
Manchester, M20 4BX
Royal Marsden Hospital
Sutton, SM2 5PT
About this study
Official title: A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
The purpose of this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).
- Conditions
- Prostatic Neoplasms
- Being tested
- JNJ-80038114
- Keywords
- 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-80038114Drug
JNJ-80038114 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET). Receives: Drug: JNJ-80038114 |
| Part 2: Dose Expansion | Experimental | Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1. Receives: Drug: JNJ-80038114 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 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 2 Years 6 Months
Parts 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 associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Measured: Up to 2 Years 6 Months
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 2 Years 6 Months
Secondary outcomes (7)
Serum Concentration of JNJ-80038114
Serum concentration of JNJ-80038114 will be determined.
Measured: Up to 2 Years 6 Months
Systemic Cytokine Concentrations
Cytokine concentrations will be determined for biomarker assessment.
Measured: Up to 2 Years 6 Months
Serum Prostate Specific Antigen (PSA) Concentration
Serum PSA concentration will be determined.
Measured: Up to 2 Years 6 Months
Number of Participants With Antibodies to JNJ-80038114
Serum samples will be analyzed for the detection of antibodies to JNJ-80038114 using a validated assay method.
Measured: Up to 2 Years 6 Months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to Prostate Cancer Working Group 3 (PCWG3) response criteria.
Measured: Up to 2 Years 6 Months
PSA Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline in PSA of 50 percent (%) or more from baseline.
Measured: Up to 2 Years 6 Months
Duration of Response (DOR)
DOR is defined as the duration 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 response criteria, or death due to any cause, whichever occurs first.
Measured: Up to 2 Years 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start15 Nov 2022
- Primary completion26 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 39 participants (actual)
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
- NCT05441501
- Sponsor's protocol ID
- CR109209
- Other IDs
- 80038114PCR1001
- Status last verified
- Mar 2025
- First submitted
- 28 Jun 2022
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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
Hudson A, Jayaram A, Garmezy B, Zorko NA, Zarrabi KK, Mathews L, Rupnow B, Li M, Ghosh D, Urtishak K, Francis P, Wang SC, Attiyeh E, de Bono J. A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2026 Jan 6;96(1):5. doi: 10.1007/s00280-025-04846-w.
PubMed 41493473
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JNJ-80038114, a T-Cell Redirecting Agent Targeting Prostate Specific Membrane Antigen (PSMA), for Advanced Stage Prostate Cancer
- ClinicalTrials.gov ID
- NCT05441501
- Acronym / sponsor ID
- CR109209
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 26 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 1 Jul 2022 (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 this study is to determine recommended phase 2 dose(s) (RP2Ds) of JNJ-80038114 in Part 1 (dose escalation) and to determine the safety at the RP2D(s) in Part 2 (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Dose Escalation | Experimental | Drug: JNJ-80038114Participants will receive JNJ-80038114. The dose levels will be escalated based on the dose limiting toxicities (DLTs) evaluation by the study evaluation team (SET). |
| Part 2: Dose Expansion | Experimental | Drug: JNJ-80038114Participants will receive JNJ-80038114 at the recommended Phase 2 dose (RP2D) determined in Part 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- At least 1 prior treatment for mCRPC
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ functions as defined by certain laboratory values
Key exclusion criteria (5 listed)
- Concurrent anticancer therapy
- Severe or long-lasting side effects related to prior anticancer therapy
- Known allergies to JNJ-80038114 or its excipients
- Brain metastasis or known seizure history
- Significant infections or lung, heart or other medical conditions
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-80038114JNJ-80038114 will be administered. | Drug | Part 1: Dose Escalation, Part 2: Dose Expansion |
Primary outcome
Parts 1 and 2: Number of Participants With Adverse Events (AEs)
Time frame: Up to 2 Years 6 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.
Parts 1 and 2: Number of Participants With AEs by Severity
Time frame: Up to 2 Years 6 Months
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 associated neurologic toxicity events will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Time frame: Up to 2 Years 6 Months
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.
7 secondary outcomes
Serum Concentration of JNJ-80038114
Time frame: Up to 2 Years 6 Months
Systemic Cytokine Concentrations
Time frame: Up to 2 Years 6 Months
Serum Prostate Specific Antigen (PSA) Concentration
Time frame: Up to 2 Years 6 Months
Number of Participants With Antibodies to JNJ-80038114
Time frame: Up to 2 Years 6 Months
Objective Response Rate (ORR)
Time frame: Up to 2 Years 6 Months
PSA Response Rate
Time frame: Up to 2 Years 6 Months
Duration of Response (DOR)
Time frame: Up to 2 Years 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Derived from this study: PubMed 41493473Hudson A, Jayaram A, Garmezy B, Zorko NA, Zarrabi KK, Mathews L, Rupnow B, Li M, Ghosh D, Urtishak K, Francis P, Wang SC, Attiyeh E, de Bono J. A phase 1, first-in-human, dose escalation study of JNJ-80038114, a PSMAxCD3 bispecific antibody, in participants with metastatic castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2026 Jan 6;96(1):5. doi: 10.1007/s00280-025-04846-w.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/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
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-80038114 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 6 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 7 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: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Parts 1 and 2: Number of Participants With Adverse Events (AEs) (time frame: Up to 2 Years 6 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 NCT05441501, 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 4 Mar 2025.