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Purpose

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).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Male
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
JNJ-78278343 + Combination agent: Part 1 (Dose Escalation) and Part 2 (Dose Expansion) 		Participants will receive pasritamig (JNJ-78278343) and combination agent (cetrelimab, cabazitaxel, docetaxel, apalutamide, enzalutamide, Darolutamide, abiraterone acetate plus prednisone, Lutetium Lu-177 vipivotide tetraxetan and JNJ-101556143) during Part 1 (dose escalation). The dose of pasritamig (JNJ-78278343) will be escalated sequentially until a recommended phase 2 regimen (RP2R). Participants will receive pasritamig (JNJ-78278343) and combination agent treatment at the putative RP2R in Part 2 (dose expansion).
  • Drug: Pasritamig
    Pasritamig will be administered.
    Other names:
    • JNJ-78278343
  • Drug: Cetrelimab
    Cetrelimab will be administered by intravenous infusion.
    Other names:
    • JNJ-63723283
  • Drug: Cabazitaxel
    Cabazitaxel will be administered by intravenous infusion.
  • Drug: Docetaxel
    Docetaxel will be administered by intravenous infusion.
  • Drug: Apalutamide
    Apalutamide will be administered orally.
  • Drug: Enzalutamide
    Enzalutamide will be administered orally.
  • Drug: Darolutamide
    Darolutamide will be administered orally.
  • Drug: Abiraterone acetate plus prednisone (AAP)
    Abiraterone acetate plus prednisone (AAP) will be administered orally.
  • Drug: Lutetium Lu-177 vipivotide tetraxetan
    Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
  • Drug: JNJ-101556143
    JNJ-101556143 will be administered orally.

Recruiting Locations

Florida Cancer Specialists
Sarasota, Florida 34232

Start Midwest
Grand Rapids, Michigan 49546

Washington University School Of Medicine
St Louis, Missouri 63110

Perlmutter Cancer Center at NYU Langone Brooklyn
Brooklyn, New York 11223

Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501

NYU Langone Health
New York, New York 10016

Sidney Kimmel Cancer Center - Jefferson Health
Philadelphia, Pennsylvania 19107

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.