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Prostatic NeoplasmsPhase 2NCT07832292

A Study of JNJ-101556143 in Participants With Metastatic Prostate Cancer

A Phase 2 study testing JNJ-101556143 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 14 sites in 4 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 evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. 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-101556143
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
14 sitesin 4 countries
Study dates
16 Sep 2026to 20 May 2030
Phase
Phase 2
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

  • Have histologically confirmed adenocarcinoma of the prostate. Primary (or pathologic evidence of conversion to) small cell carcinoma, carcinoid tumor, mixed neuroendocrine carcinoma, large cell neuroendocrine carcinoma, or sarcoma of the prostate is disallowed
  • Progressive metastatic androgen pathway modulation-resistant prostate cancer (mAPMR) defined as having a Prostate-Specific Antigen (PSA) level greater than or equal (>=) 10 nanograms per milliliter (ng/mL) and at least one of the following: (a) PSA progression defined as at least 2 consecutive increases in PSA value over a previous reference value measured at least 1 week apart. (b) Progressive disease or new lesion(s) in the lymph nodes, bones, or viscera on conventional imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) as defined by response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) and/or on bone scan per Prostate Cancer Working Group 4 (PCWG4) while on Androgen Deprivation Therapy (ADT) (either surgically [bilateral orchiectomy] or with medication). Local-regional disease including invasive disease of rectum, bladder, pelvis is allowed as long as participant has a current or past history of distant metastasis (M1 disease). Participants in Part 1 must have measurable disease per RECIST v1.1 by conventional imaging with CT or MRI (chest, abdomen, and pelvis) and/or Technetium-99^m (99^mTc) bone scan confirmed by Blinded Independent Central Review (BICR) at the time of screening
  • Prior bilateral orchiectomy or medical castration (receiving ongoing ADT with a Gonadotropin-Releasing Hormone (GnRH) analog [agonist or antagonist]) with castrate level of serum testosterone (less than [<] 50 nanograms per deciliter [ng/dL] or 1.7 nanomoles per liter [nmol/L]) prior to the first dose of trial intervention and must continue this therapy throughout the treatment phase
  • Have discontinued concurrent use of any non-investigational systemic anticancer therapy (that is, cytotoxic chemotherapy, Androgen Receptor Pathway Inhibitor (ARPI), radiation therapy) within 2 weeks or Lutetium-177 Prostate-Specific Membrane Antigen-617 (177^Lu PSMA-617) within 6 weeks prior to first dose of trial intervention, or any investigational drugs within 3 months of first dose of trial intervention
  • Toxicity related to prior anticancer treatment that is deemed clinically relevant must have resolved to common terminology criteria for adverse events (CTCAE) Version 6.0 Grade 1 or better

Who cannot join

  • Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per investigator assessment)
  • Suspected or known allergies, hypersensitivity, or intolerance to JNJ-101556143 or its excipients
  • Had major surgery or had significant traumatic injury less than or equal to 28 days of the first dose of trial intervention. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate
  • Spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
  • Solid organ or bone marrow transplantation

Trial locations and contacts

14 sites in 4 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

14 sites in 4 countries

United States7 sites, 7 recruiting

  • Urology of Indiana

    Carmel, Indiana, 46032

    Recruiting

  • Associated Urological Specialists

    Chicago Ridge, Illinois, 60415

    Recruiting

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138

    Recruiting

  • Southern Urology LLC

    Lafayette, Louisiana, 70508

    Recruiting

  • Advanced Urology Institute

    Largo, Florida, 33771

    Recruiting

  • Greater Boston Urology

    Plymouth, Massachusetts, 02360

    Recruiting

  • Associated Medical Professionals

    Syracuse, New York, 13210

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Icon Ctr Chermside

    Chermside, 4032

    Recruiting

  • Epworth Healthcare

    East Melbourne, 3002

    Recruiting

  • Icon Cancer Ctr Hobart

    Hobart, 7000

    Recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, 5037

    Recruiting

Other trials in Australia

China2 sites, 2 recruiting

  • Sun Yat Sen University Cancer Center

    Guangzhou, 510060

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, 325000

    Recruiting

Other trials in China

Japan1 site, 1 recruiting

  • Kobe University Hospital

    Kobe, 650 0017

    Recruiting

Other trials in Japan

About this study

Official title: A Phase 2, Open-label, Multicenter, Single-arm Trial of JNJ-101556143, an Androgen Receptor-targeted Regulated Induced Proximity Targeting Chimera (RIPTAC™) Therapeutic in Participants With Metastatic Androgen Pathway Modulation-Resistant Prostate Cancer

The purpose of this study is to evaluate how well JNJ-101556143 works in participants with metastatic androgen pathway modulation-resistant prostate cancer (mAPMR), an advanced form of prostate cancer that has spread and no longer responds to hormone therapy. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.

Being tested
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-101556143Drug

    Participants will receive JNJ-101556143 orally.

Study groups in NCT07832292
Study groupRoleWhat they receive
JNJ-101556143ExperimentalParticipants will receive JNJ-101556143 orally once daily in a 28-day treatment cycle until confirmed radiographic progression by blinded independent central review (BICR) or unequivocal clinical progression, or any other protocol-defined discontinuation criteria is met.
Receives: Drug: JNJ-101556143

What is being measured

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

  1. Overall Response Rate (ORR)

    Confirmed overall response, is defined as having either confirmed complete response (CR) or partial response (PR) per response evaluation criteria in solid tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR) prior to any subsequent anti-cancer therapy.

    Measured: Up to 2 years and 8 months

Secondary outcomes (8)

  1. Duration of Response (DoR)

    DoR is defined as the time from the date of first documented response for a confirmed radiographic response (CR or PR) per RECIST v1.1 until the date of documented radiographic progression by BICR, or death, whichever comes first.

    Measured: Up to 2 years and 8 months

  2. Radiographic Progression-Free Survival (rPFS)

    rPFS is defined as the time from the date of initiation of therapy until the date of radiographic disease progression or death, whichever comes first.

    Measured: Up to 2 years and 8 months

  3. Time to Symptomatic Progression (TSP)

    TSP is defined as the time from the first dose of trial intervention until the date of symptomatic progression or death, whichever comes first.

    Measured: Up to 2 years and 8 months

  4. Number of Participants with Treatment-Emergent Adverse Event (TEAE) by Severity

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Severity scale defined as 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 8 months

  5. Number of Participants with Abnormalities in Clinical Laboratory Tests

    Number of participants with abnormalities in clinical laboratory tests will be reported.

    Measured: Up to 2 years and 8 months

  6. Minimum Plasma Concentration (Cmin) of JNJ-101556143

    Minimum plasma concentration of JNJ-101556143 will be reported.

    Measured: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)

  7. Maximum Plasma Concentration (Cmax) of JNJ-101556143

    Maximum plasma concentration of JNJ-101556143 will be reported.

    Measured: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)

  8. Area Under the Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) of JNJ-101556143

    AUC0-24h is the area under the plasma concentration-time curve from the time of JNJ-101556143 dose administration up to 24-hour dosing interval.

    Measured: Pre-dose (0 hours); 2 to 3 hours post dose from Cycle 1 to Cycle 2 and 4 to 8 hours post dose from Cycle 1 to Cycle 2 (Each Cycle Duration= 28 days)

Timeline

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

  1. First posted21 Sep 2026
  2. Study start16 Sep 2026
  3. Primary completion17 May 2029 (estimated)
  4. Study completion20 May 2030 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07832292
Sponsor's protocol ID
101556143PCR2001
Other IDs
101556143PCR2001
Status last verified
Nov 2026
First submitted
16 Sep 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JNJ-101556143 in people with Prostatic Neoplasms, run by Janssen Research & Development, LLC at 14 sites in 4 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 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: 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 14 sites in United States, Australia, China, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall Response Rate (ORR) (time frame: Up to 2 years and 8 months). 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 NCT07832292.

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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