A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

Recruiting now · Phase 1

Conditions studied: Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer

In brief

The purpose of this study is to identify the recommended phase 2 regimen(s) RP2R(s) of pasritamig and combination regimens in Part 1 (dose escalation) and to determine safety at the putative RP2R(s) of pasritamig with the combination regimens in Part 2 (dose expansion).

Key facts

Study ID

NCT05818683

Run by

Janssen Research & Development, LLC

People needed

300

Starts

2023-04-26

Expected to finish

2028-05-23

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Florida Cancer Specialists — Sarasota, Florida, United States (enrolling)
• Start Midwest — Grand Rapids, Michigan, United States (enrolling)
• Washington University School Of Medicine — St Louis, Missouri, United States (enrolling)
• Perlmutter Cancer Center at NYU Langone Brooklyn — Brooklyn, New York, United States (enrolling)
• Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island — Mineola, New York, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Sidney Kimmel Cancer Center - Jefferson Health — Philadelphia, Pennsylvania, United States (enrolling)
• Icon Cancer Centre Kurralta Park — Kurralta Park, Australia (enrolling)
• Macquarie University — Macquarie University, Australia (enrolling)
• Peter MacCallum Cancer Centre — Melbourne, Australia (enrolling)
• Princess Alexandra Hospital — Woolloongabba, Australia (enrolling)
• Hosp Univ Vall D Hebron — Barcelona, Spain (enrolling)
• Hosp Univ Fund Jimenez Diaz — Madrid, Spain (enrolling)
• Hosp. Univ. 12 de Octubre — Madrid, Spain (enrolling)
• Hosp Univ Hm Sanchinarro — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

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