Combining JNJ-78278343 with other treatments for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to identify the recommended phase 2 regimens of JNJ-78278343 in combination with either Cetrelimab, taxane chemotherapy, or androgen receptor pathway inhibitors for patients with metastatic castration-resistant prostate cancer. The trial is divided into two parts: the first part focuses on dose escalation to determine the optimal dosing, while the second part assesses the safety of the identified regimens. Participants will receive one of the combination treatments to evaluate its effectiveness and safety profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Part 1 A-G, 1I, 1J, and 1K (all combination treatments) and Parts 2B-C (cabazitaxel, docetaxel): Metastatic castration-resistant prostate cancer (mCRPC) with confirmed adenocarcinoma of the prostate as defined by prostate cancer working group 3 (PCWG3); Parts 2D-G, 2I, 2J, and 2K (apalutamide, enzalutamide, darolutamide, abiraterone acetate + prednisone \[AAP\], lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143): mCRPC: Histologically confirmed adenocarcinoma of the prostate as defined by PCWG3, with a minimum PSA of 2 nanogram \[ng\]/milliliter (mL); Part 2H (apalutamide): metastatic hormone-sensitive prostate cancer(mHSPC) with PSA greater than (\>) 0.2 ng/mL on 6 to 24 months of treatment with a next generation ARPI (apalutamide, enzalutamide, darolutamide, or abiraterone)
* Measurable or evaluable disease, except for Part 2H
* (a) Part 1A (cetrelimab) - Prior treatment for mCRPC with at least 1 prior androgen receptor pathway inhibitors (ARPI) (that is, abiraterone acetate, apalutamide, enzalutamide, darolutamide), or chemotherapy (example, docetaxel). (b) Part 1C and 2C (docetaxel), Part 1D (apalutamide), Part 1E and 2E (enzalutamide), Part 1F and 2F (darolutamide), and Part 1G, 2G (AAP), and Part 1K \& 2K (JNJ-101556143)- Prior treatment with at least 1 prior ARPI (that is, apalutamide, enzalutamide, darolutamide, or abiraterone acetate). (C) Part 1B and 2B (cabazitaxel) - Prior treatment with at least 1 prior ARPI (ie, abiraterone acetate, apalutamide, enzalutamide, darolutamide) and docetaxel. (d) Part 2D (apalutamide) - Prior treatment with at least 1 prior ARPI (e) Part 2H (apalutamide)- Participant may have received up to 6 cycles of docetaxel. The last dose of docetaxel must be administered at least 2 months prior to enrollment (f) Parts 1I, 1J, 2I \& 2J (lutetium Lu-177 vipivotide tetraxetan)- Prior treatment with at least 1 ARPI (abiraterone acetate, enzalutamide, darolutamide, or apalutamide). Participant must not have received prior cytotoxic chemotherapy or prior radioligand therapy (RLT) for mCRPC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate organ functions

Exclusion Criteria:

* Active autoimmune disease within the 12 months prior to signing consent that requires systemic immunosuppressive medications
* Toxicity related to prior anticancer therapy that has not returned to Grade less than or equal to (\<=) 1 or baseline levels (except for alopecia, vitiligo, Grade \<=2 peripheral neuropathy)
* Solid organ or bone marrow transplantation
* Known allergies, or intolerance to any of the components (example, excipients) of pasritamig, cetrelimab (Part 1A), cabazitaxel, Part 1B and 2B , docetaxel Part 1C and 2C , apalutamide (Part 1D and 2D and Part 2H), enzalutamide (Part 1E and 2E), darolutamide (Part 1F and 2F), or AAP (Part 1G and 2G), lutetium Lu-177 vipivotide tetraxetan (Parts 1I, 1J, 2I, and 2J), or JNJ-101556143 (Parts 1K \& 2K)
* Significant infections or serious lung, heart or other medical conditions

Where it's running

• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting
• Start Midwest
  Grand Rapids, Michigan, United States Recruiting
• Perlmutter Cancer Center at NYU Langone Brooklyn
  Brooklyn, Mississippi, United States Recruiting
• Washington University School Of Medicine
  St Louis, Missouri, United States Recruiting
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
  Mineola, New York, United States Recruiting
• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.