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RecruitingPhase 1 / Phase 2

Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic Prostate Cancer

Phase 1/2 Study of HLD-0915 (JNJ-101556143) in Patients With Metastatic 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 safe HLD-0915 (JNJ-101556143) is and how well it works for prostate cancer that has spread to other parts of the body. It includes men whose cancer has worsened after treatment, as well as men in other prostate cancer groups.

Assessment of the safety and efficacy of HLD-0915 (JNJ-101556143) in patients with metastatic prostate cancer who have progressed on prior systemic therapies, with further evaluation in additional prostate cancer populations.

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

Eligibility

Who can join

  • All groups: Men age 18 or older with prostate adenocarcinoma confirmed by tissue or cell tests.
  • All groups: Blood counts, kidneys, and liver must work well enough. Must be able to swallow medicine.
  • Hormone-resistant group: Cancer has spread and resists treatment that lowers testosterone. Must have had surgery to remove the testicles or be on testosterone-lowering treatment, with very low testosterone.
  • Hormone-resistant group: PSA, a blood marker for prostate cancer, must have risen during the prior treatment.
  • SOAR group: Cancer still responds to hormone treatment, and standard scans show it has spread to distant parts of the body.
  • SOAR group: PSA must be at least 0.2 ng/mL after 180–365 days of a newer hormone-blocking drug called an ARPI. Scans and PSA must show no worsening during that treatment.
  • Other hormone-sensitive groups: Cancer still responds to hormone treatment, and standard scans show distant spread. PSA must be above 2.0 ng/mL and testosterone above 150 ng/mL.

Who can't join

  • All groups: A recent major bleed or a known bleeding disorder.
  • All groups: Tissue tests show neuroendocrine or small cell cancer, which are special types of cancer cells.
  • All groups: Ongoing steroid use at a dose equal to more than 10 mg of prednisone each day.
  • All groups: A past or current major medical condition.
  • Hormone-resistant group: Cancer drugs that treat the whole body or experimental drugs within 2 weeks before the first study dose. Some drugs require a longer wait.
  • SOAR group: Any past cell-killing chemotherapy for prostate cancer.
  • Other hormone-sensitive groups: Cancer spread only to nearby lymph nodes in the pelvis.

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

Official eligibility criteria

Patients must meet the following criteria to be eligible study participation: Key Inclusion Criteria: All Study Arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D): Males ≥ 18 years old Histological, pathological, and/or cytological confirmation of prostate adenocarcinoma Adequate hematological, renal, and hepatic function. Able to swallow oral medication mCRPC Arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Prior orchiectomy or ongoing androgen-deprivation therapy and a castrate level of serum testosterone Progressive mCRPC defined as having demonstrated PSA progression on the prior regimen SOAR Arm (Phase 2 Part 2A) mHSPC with distant metastatic disease based on conventional imaging PSA ≥0.2 ng/mL, following treatment with next generation ARPI for at least 180 days and up to 365 days No evidence of radiographic or PSA progression while receiving ARPI mHSPC arms (Phase 2 Part 2B, 2C \& 2D) serum testosterone \>150ng/ml mHSPC with distant metastatic disease based on conventional imaging and PSA \>2.0 ng/mL Key Exclusion Criteria: All arms (Phase 1 Part 1 \& 2, Phase 2 Part 1, Part 2A, 2B, 2C \& 2D): Has experienced a recent major bleed or has a known bleeding disorder Tumors exhibiting neuroendocrine or small cell carcinoma component by histopathology Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day Prior or ongoing significant medical condition mCRPC arms: (Phase 1 Part 1 \& 2, Phase 2 Part 1): Has received systemic anti-cancer therapy or investigational drugs within 2 weeks prior to first dose of study drug with certain exceptions requiring longer washout periods SOAR arm (Phase 2 Part 2A) Has received any prior cytotoxic chemotherapy for prostate cancer mHSPC arms (Phase 2 Part 2B, 2C \& 2D) regional pelvic lymph node disease only

Study sites (17)

CO

CT

FL

LA

MA

MI

NC

NE

NY

SC

TN

TX

VA