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).
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
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)
Sequential
Pasritamig
DrugPasritamig will be administered.
Cetrelimab
DrugCetrelimab will be administered by intravenous infusion.
Cabazitaxel
DrugCabazitaxel will be administered by intravenous infusion.
Docetaxel
DrugDocetaxel will be administered by intravenous infusion.
Apalutamide
DrugApalutamide will be administered orally.
Enzalutamide
DrugEnzalutamide will be administered orally.
Darolutamide
DrugDarolutamide will be administered orally.
Abiraterone acetate plus prednisone (AAP)
DrugAbiraterone acetate plus prednisone (AAP) will be administered orally.
Lutetium Lu-177 vipivotide tetraxetan
DrugLutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
JNJ-101556143
DrugJNJ-101556143 will be administered orally.
Part 1: Number of Participants With Dose Limiting Toxicity (DLT)
DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity or hematologic toxicity.
Part 1 and Part 2: Number of Participants with Adverse Events (AEs) by Severity
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 with the exception of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome events, which will be graded by American Society for Transplantation and Cellular Therapy (ASTCT) guidelines. Severity scale ranges from grade 1 (mild) to grade 5 (death). Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening and Grade 5= death related to adverse event.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better without evidence of bone progression according to Prostate Cancer Working Group 3 (PCWG3) criteria.
Prostate Specific Antigen (PSA) Response Rate
PSA response rate is defined as the percentage of participants with a confirmed decline of PSA of 50 percent (%) or more from baseline.
Radiographic Progression-free Survival (rPFS)
rPFS is defined time from the date of first dose of pasritamig until the date of objective disease progression or death, whichever comes first.
Time to Response (TTR)
TTR is defined for the responders as the time from the date of first dose of to the date of first documented response that is subsequently confirmed.
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