Prostatic NeoplasmsPhase 1NCT04644770

A Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

A Phase 1 study testing JNJ-69086420, JNJ-78278343 and Stereotactic body radiation therapy in people with Prostatic Neoplasms and Adenocarcinoma, run by Janssen Research & Development, LLC at 11 sites in United States.

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) (RP2D[s]) of JNJ-69086420 in Part 1 (Dose Escalation), to determine safety and preliminary signs of clinical activity at the RP2D(s) in Part 2 (Dose Expansion), to determine safety of JNJ-69086420 at the RP2D(s) as a combination therapy in Part… Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Prostatic Neoplasms, Adenocarcinoma
What is being tested?: JNJ-69086420, JNJ-78278343 and Stereotactic body radiation therapy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 11 sitesUnited States
Study dates: 12 Nov 2020to 30 Dec 2026
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

For Part 1, Part 2, Part 3: Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (for example [e.g.], abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition: Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan, with or without prior chemotherapy, Part 3: prior taxane or other chemotherapy is acceptable but not required \& For Part 4a: metastatic HSPC, For Part 4b: disease that can be treated with less than or equal to (<=) 5 radiation fields and no visceral metastases
Parts 1, 2 \& 3: Prior orchiectomy or medical castration, or, for 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. This criterion does not apply to Part 4
Palliative radiotherapy (e.g. soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (e.g., bone pain), which may be used any time prior to first dose
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions as reflected in laboratory parameters

Who cannot join

Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy, other systemic anti-neoplastic therapy <=30 days prior to the first dose of study drug except for luteinizing hormone-releasing hormone agonists/antagonists or GnRH agonists/antagonists. Novel androgen axis drugs <=14 days prior to the first dose of study drug. In addition: Part 2b: Must not have received prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors, Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is required, but must have been completed >42 days prior to first dose of study drug, Part 3: Must not have received prior treatment with JNJ-78278343, Part 4: Must not have received ADT or AR-targeted therapy less than or equal to (<=) 56 days prior to first dose of study drug
Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics. For Part 3, known allergies, hypersensitivity, or intolerance to JNJ-78278343 or its excipients or protein therapeutics
Active or chronic hepatitis B or hepatitis C infection

Trial locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

University of Chicago
Chicago, Illinois, 60637
Case Western Reserve University
Cleveland, Ohio, 44106
City of Hope
Duarte, California, 91010
Mayo Clinic in Florida
Jacksonville, Florida, 32224
East Jefferson General Hospital
Metairie, Louisiana, 70006
Tulane University Hospital & Clinics
New Orleans, Louisiana, 70112
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
XCancer Omaha / Urology Cancer Center
Omaha, Nebraska, 68130
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Rochester
Rochester, Minnesota, 55905
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112

Other trials in United States

About this study

Official title: A Phase 1 Study of JNJ-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer

Conditions: Prostatic Neoplasms, Adenocarcinoma
Being tested: JNJ-69086420, JNJ-78278343, Stereotactic body radiation therapy
Medical subject headings: Prostatic Neoplasms, Adenocarcinoma

What participants receive

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

JNJ-69086420Drug
Also called Actinium-225-DOTA-h11B6
Participants will receive JNJ-69086420.
JNJ-78278343Drug
Participants will receive JNJ-78278343.
Stereotactic body radiation therapyRadiation
Participants will receive stereotactic body radiaition therapy.

Study groups in NCT04644770
Study group	Role	What they receive
Part 1: Dose Escalation	Experimental	Participants will receive JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified. Receives: Drug: JNJ-69086420
Part 2: Dose Expansion	Experimental	Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1. Receives: Drug: JNJ-69086420
Part 3: Combination Therapy	Experimental	Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343. Receives: Drug: JNJ-69086420; Drug: JNJ-78278343
Part 4: HSPC Expansion	Experimental	Participants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b). Receives: Drug: JNJ-69086420; Radiation: Stereotactic body radiation therapy

What is being measured

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

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
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 and 4 months
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Number of participants with DLT will be assessed. 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 and 4 months
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.
Measured: Up to 2 years and 4 months

Secondary outcomes (8)

Percentage of Participants with Prostate Specific Antigen (PSA) Response
PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline and that is subsequently confirmed.
Measured: Up to 2 years and 4 months
Overall Response Rate (ORR)
ORR is defined as the percentage 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 Working Group 3 (PCWG3).
Measured: Up to 2 years and 4 months
Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
Cmax is defined as the maximum observed serum concentration/radioactivity of JNJ-69086420.
Measured: Up to 2 years and 4 months
Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
Tmax is defined as time to reach maximum observed serum concentration/radioactivity of JNJ-69086420.
Measured: Up to 2 years and 4 months
Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420
AUC(0-t) is defined as the area under the serum concentration-time curve from time zero to t of JNJ-69086420.
Measured: Up to 2 years and 4 months
Number of Participants With Anti-JNJ-69086420 Antibodies
Number of participants with anti-JNJ-69086420 antibodies will be assessed to evaluate the potential immunogenicity.
Measured: Up to 2 years and 4 months
Part 3: Serum Concentration of JNJ-78278343
Venous blood samples will be collected for assessment of serum concentrations of JNJ-78278343.
Measured: Up to 2 years and 4 months
Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies
Number of participants with anti-JNJ-78278343 antibodies will be assessed to evaluate the potential immunogenicity.
Measured: Up to 2 years and 4 months

Timeline

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

12 Nov 202030 Dec 2026

First posted25 Nov 2020
Study start12 Nov 2020
Primary completion8 Dec 2026 (estimated)
Study completion30 Dec 2026 (estimated)

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: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04644770
Sponsor's protocol ID: CR108817
Other IDs: 69086420PCR1001
Status last verified: Nov 2026
First submitted: 20 Nov 2020
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

Lehner F, Salemi S, Millan C, Kundig C, Eberli D. Inhibition of Growth and Induction of Apoptosis of Human Prostate Cancer Cells by Enzymatic Blockage of Kallikreins. Prostate Cancer. 2026 Jan 11;2026:7871208. doi: 10.1155/proc/7871208. eCollection 2026.
PubMed 41531507

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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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-69086420, an Actinium-225-Labeled Antibody Targeting Human Kallikrein-2 (hK2) for Advanced Prostate Cancer
ClinicalTrials.gov ID: NCT04644770
Acronym / sponsor ID: CR108817
Conditions: Prostatic Neoplasms, Adenocarcinoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 144 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: 12 Nov 2020 (actual)
Primary completion: 8 Dec 2026 (estimated)
Study completion: 30 Dec 2026 (estimated)
First posted: 25 Nov 2020 (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.

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-69086420Participants will receive JNJ-69086420 with one or multiple doses. The dose levels will be escalated based on the dose limiting toxicities (DLT) evaluation by Study Evaluation Team (SET) until the recommended Phase 2 Dose (RP2D) has been identified.
Part 2: Dose Expansion	Experimental	Drug: JNJ-69086420Participants in one or more cohorts will receive JNJ-69086420 at the RP2D(s) determined in Part 1.
Part 3: Combination Therapy	Experimental	Drug: JNJ-69086420, Drug: JNJ-78278343Participants will receive JNJ-69086420 at the determined RP2D(s) and fixed dose of JNJ-78278343.
Part 4: HSPC Expansion	Experimental	Drug: JNJ-69086420, Radiation: Stereotactic body radiation therapyParticipants with HSPC will receive JNJ-69086420 at the RP2D(s) in Part 4(a), and JNJ-69086420 following stereotactic body radiation therapy in Part 4(b).

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

For Part 1, Part 2, Part 3: Metastatic castration resistant prostate cancer (mCRPC) with histologic confirmation of adenocarcinoma (adenocarcinoma with small-cell or neuroendocrine features is allowed) with prior exposure to at least one androgen receptor (AR) targeted therapy (for example [e.g.], abiraterone acetate, enzalutamide, apalutamide, darolutamide). In addition: Part 1: prior taxane or other chemotherapy is acceptable but not required. Part 2a: prior taxane or other chemotherapy required, Part 2b: no prior taxane or other chemotherapy, Part 2c: mCRPC that has progressed after prior treatment with lutetium Lu-177 vipivotide tetraxetan, with or without prior chemotherapy, Part 3: prior taxane or other chemotherapy is acceptable but not required \& For Part 4a: metastatic HSPC, For Part 4b: disease that can be treated with less than or equal to (<=) 5 radiation fields and no visceral metastases
Parts 1, 2 \& 3: Prior orchiectomy or medical castration, or, for 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. This criterion does not apply to Part 4
Palliative radiotherapy (e.g. soft tissue lesions) must be completed greater than (>) 2 weeks prior to start of study drug except for palliative radiotherapy for pain (e.g., bone pain), which may be used any time prior to first dose
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ functions as reflected in laboratory parameters

Key exclusion criteria (5 listed)

Prior treatment with radium Xofigo (Ra 223 dichloride), strontium, samarium, or other radioconjugate therapy, other systemic anti-neoplastic therapy <=30 days prior to the first dose of study drug except for luteinizing hormone-releasing hormone agonists/antagonists or GnRH agonists/antagonists. Novel androgen axis drugs <=14 days prior to the first dose of study drug. In addition: Part 2b: Must not have received prior treatment with chemotherapy (eg, docetaxel) or poly ADP ribose polymerase (PARP) inhibitors, Part 2c: Prior treatment with lutetium Lu-177 vipivotide tetraxetan is required, but must have been completed >42 days prior to first dose of study drug, Part 3: Must not have received prior treatment with JNJ-78278343, Part 4: Must not have received ADT or AR-targeted therapy less than or equal to (<=) 56 days prior to first dose of study drug
Known history of myelodysplastic syndrome, leukemia, or hematological malignancy with features suggestive of myelodysplastic syndrome/acute myeloid leukemia at any timepoint
Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, radiation tissue fibrosis, or peripheral neuropathy)
Known allergies, hypersensitivity, or intolerance to JNJ-69086420 or its excipients and protein therapeutics. For Part 3, known allergies, hypersensitivity, or intolerance to JNJ-78278343 or its excipients or protein therapeutics
Active or chronic hepatitis B or hepatitis C infection

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-69086420Also: Actinium-225-DOTA-h11B6Participants will receive JNJ-69086420.	Drug	Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Combination Therapy, Part 4: HSPC Expansion
JNJ-78278343Participants will receive JNJ-78278343.	Drug	Part 3: Combination Therapy
Stereotactic body radiation therapyParticipants will receive stereotactic body radiaition therapy.	Radiation	Part 4: HSPC Expansion

Primary outcome

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Time frame: Up to 2 years and 4 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.
Part 1: Number of Participants with Dose-Limiting Toxicity (DLT)
Time frame: Up to 2 years and 4 months
Number of participants with DLT will be assessed. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Number of Participants with AEs by Severity
Time frame: Up to 2 years and 4 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.

8 secondary outcomes

Percentage of Participants with Prostate Specific Antigen (PSA) Response
Time frame: Up to 2 years and 4 months
Overall Response Rate (ORR)
Time frame: Up to 2 years and 4 months
Maximum Observed Serum Concentration/Radioactivity (Cmax) of JNJ-69086420
Time frame: Up to 2 years and 4 months
Time to Reach Maximum Observed Serum Concentration/Radioactivity (Tmax) of JNJ-69086420
Time frame: Up to 2 years and 4 months
Area Under the Serum Concentration-time Curve From Time Zero to t Time (AUC[0-t]) of JNJ-69086420
Time frame: Up to 2 years and 4 months
Number of Participants With Anti-JNJ-69086420 Antibodies
Time frame: Up to 2 years and 4 months
Part 3: Serum Concentration of JNJ-78278343
Time frame: Up to 2 years and 4 months
Part 3:Number of Participants With Anti-JNJ-78278343 Antibodies
Time frame: Up to 2 years and 4 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.
Derived from this study: PubMed 41531507Lehner F, Salemi S, Millan C, Kundig C, Eberli D. Inhibition of Growth and Induction of Apoptosis of Human Prostate Cancer Cells by Enzymatic Blockage of Kallikreins. Prostate Cancer. 2026 Jan 11;2026:7871208. doi: 10.1155/proc/7871208. eCollection 2026.
Individual participant dataSharing planned: 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

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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. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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: 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 11 sites in United States. 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?

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: Up to 2 years and 4 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 NCT04644770, 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.