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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: JNJ-101556143

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study1@its.jnj.com

Study Locations

• Australia
  • Chermside, Australia, 4032
    • Recruiting
    • Icon Ctr Chermside
  • East Melbourne, Australia, 3002
    • Recruiting
    • Epworth Healthcare
  • Hobart, Australia, 7000
    • Recruiting
    • Icon Cancer Ctr Hobart
  • Kurralta Park, Australia, 5037
    • Recruiting
    • Icon Cancer Centre Kurralta Park
• China
  • Guangzhou, China, 510060
    • Recruiting
    • Sun Yat Sen University Cancer Center
  • Wenzhou, China, 325000
    • Recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
• Japan
  • Kobe, Japan, 650 0017
    • Recruiting
    • Kobe University Hospital
• United States
  • Florida
    • Largo, Florida, United States, 33771
      • Recruiting
      • Advanced Urology Institute
  • Illinois
    • Chicago Ridge, Illinois, United States, 60415
      • Recruiting
      • Associated Urological Specialists
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Recruiting
      • Urology of Indiana
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Recruiting
      • Southern Urology LLC
  • Massachusetts
    • Plymouth, Massachusetts, United States, 02360
      • Recruiting
      • Greater Boston Urology
  • New York
    • Syracuse, New York, United States, 13210
      • Recruiting
      • Associated Medical Professionals
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Recruiting
      • The Conrad Pearson Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JNJ-101556143; Participants 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.	Drug: JNJ-101556143; Participants will receive JNJ-101556143 orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years and 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 2 years and 8 months
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.	Up to 2 years and 8 months
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.	Up to 2 years and 8 months
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.	Up to 2 years and 8 months
Number of Participants with Abnormalities in Clinical Laboratory Tests	Number of participants with abnormalities in clinical laboratory tests will be reported.	Up to 2 years and 8 months
Minimum Plasma Concentration (Cmin) of JNJ-101556143	Minimum plasma concentration of JNJ-101556143 will be reported.	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)
Maximum Plasma Concentration (Cmax) of JNJ-101556143	Maximum plasma concentration of JNJ-101556143 will be reported.	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)
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.	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)

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2026
• Primary Completion (Estimated): May 17, 2029
• Study Completion (Estimated): May 20, 2030

Study Registration Dates

• First Submitted: September 16, 2026
• First Submitted That Met QC Criteria: September 16, 2026
• First Posted (Actual): September 21, 2026

Study Record Updates

• Last Update Posted (Actual): November 3, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 101556143PCR2001; 101556143PCR2001 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No