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

NCT07832292 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 101556143PCR2001
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 5

Brief 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. The study will measure the overall response (tumor shrinkage or disappearance) following treatment with JNJ-101556143.

Conditions

Prostatic Neoplasms

Outcome Measures

Primary Outcomes (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.

  Up to 2 years and 8 months

Secondary Outcomes (8)

• Duration of Response (DoR)

  Up to 2 years and 8 months

• Radiographic Progression-Free Survival (rPFS)

  Up to 2 years and 8 months

• Time to Symptomatic Progression (TSP)

  Up to 2 years and 8 months

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

  Up to 2 years and 8 months

• Number of Participants with Abnormalities in Clinical Laboratory Tests

  Up to 2 years and 8 months

Study Arms (1)

JNJ-101556143

EXPERIMENTAL

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

Interventions

JNJ-101556143 DRUG

Participants will receive JNJ-101556143 orally.

JNJ-101556143

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (5)

Southern Urology LLC

Lafayette, Louisiana, 70508, United States

RECRUITING

Greater Boston Urology

Plymouth, Massachusetts, 02360, United States

RECRUITING

Associated Medical Professionals

Syracuse, New York, 13210, United States

RECRUITING

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

RECRUITING

Sun Yat Sen University Cancer Center

Guangzhou, 510060, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

844-434-4210; Participate-In-This-Study1@its.jnj.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2026
• First Posted: September 21, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): May 17, 2029
• Study Completion (Estimated): May 20, 2030
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (4); CN (1)