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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well JNJ-101556143 works for people with prostate cancer that has spread and no longer responds to hormone therapy. It will check whether the drug shrinks tumors or makes them disappear.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate adenocarcinoma, a type of cancer, confirmed by a tissue test. Certain other prostate cancer types are not allowed.
  • Have cancer that has spread and is getting worse despite treatment to lower testosterone. PSA, a blood marker for prostate cancer, must be at least 10 ng/mL.
  • Show worsening cancer through at least two PSA rises measured at least one week apart, or through scans showing growing or new cancer.
  • For Part 1, have cancer that can be measured on scans and confirmed by an independent review team.
  • Have had both testicles removed or be taking medicine to lower testosterone. Testosterone must be below 50 ng/dL before treatment. People taking this medicine must continue it during the study.
  • Have stopped other cancer treatments within the listed time periods before the first study dose: 2 weeks for chemotherapy, certain hormone-blocking drugs, or radiation; 6 weeks for lutetium-177 PSMA-617; and 3 months for experimental drugs.
  • Important side effects from earlier cancer treatment must have improved to mild or be gone.

Who can't join

  • Have uncontrolled kidney disease, inflammation of the pancreas, or liver disease. Exceptions include Gilbert's syndrome, gallstones with no symptoms, cancer that has spread to the liver, or stable long-term liver disease approved by the study doctor.
  • Have a known or suspected allergy to JNJ-101556143 or its ingredients, or cannot tolerate them.
  • Have had major surgery or a serious injury within 28 days before the first study dose. Planned surgery using only local numbing medicine is allowed.
  • Have pressure on the spinal cord, unless it has been fully treated and the condition has been stable for 28 days.
  • Have had an organ or bone marrow transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (4)

LA

MA

NY

TN