A Study of Pasritamig With or Without JNJ-87189401 Versus Placebo for Late Line Metastatic Castration-resistant Prostate Cancer (mCRPC)

Conditions

• Metastatic Castration-resistant Prostatic Neoplasms

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pasritamig — BIOLOGICAL
  Pasritamig will be administrated through IV infusion.
• Placebo — OTHER
  Placebo will be administrated through IV infusion.
• Best Supportive Care (BSC) — DRUG
  BSC will be administered at the discretion of the treating physician.
• JNJ-87189401 — BIOLOGICAL
  JNJ-87189401 will be administered.

Study Details

The purpose of this study is to evaluate the overall survival (length of time from the start of study to date of death from any cause) for pasritamig (JNJ-78278343) in Part 1 in combination with best supportive care (BSC) and in Part 2 with JNJ-87189401+BSC as compared to placebo with BSC in participants with metastatic castration-resistant prostate cancer (mCRPC; a stage of cancer that has spread beyond the prostate gland and is no longer responding to hormone therapies).

Key Dates

First listed

Sep 10, 2025

Start date

Sep 2, 2025

Status verified

Aug 2026

Primary completion

Aug 18, 2028

Completion

Aug 18, 2028

Study Design

Enrollment

1,203 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: Pasritamig+Best Supportive Care (BSC)
  Participants in Part 1 will receive 2 step-up doses of pasritamig intravenously (IV) followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
• Placebo Comparator: Part 1: Placebo+BSC
  Participants in Part 1 will receive 2 step-up doses of placebo IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
• Experimental: Part 2: Pasritamig+BSC
  Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
• Experimental: Part 2: Pasritamig+JNJ-87189401+BSC
  Participants in Part 2 will receive 2 step-up doses of pasritamig IV followed by the target dose. JNJ-87189401 will be administered with the first target dose of pasritamig. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.
• Placebo Comparator: Part 2: Placebo +BSC
  Participants in Part 2 will receive 2 step-up doses of placebo IV followed by the target dose. Participants will receive study treatment until confirmed progressive disease, death, intolerable toxicity, withdrawal of consent, or end of the study, whichever occurs first. All participants may receive BSC (defined as palliative external beam radiation, low dose steroids, pain medication, bone sparing agents, and needed palliative procedures) at the discretion of the physician.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to 2 years and 8 months ]

Central Contacts

• Study Contact
  844-434-4210
  [email protected]

Locations (54)

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