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

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 912 studies on the registry; 76 are open to participants now.

Of its 278 completed or terminated interventional studies of FDA-regulated products, 131 (47%) have results posted.

Study arms

• 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 · Drug: Cetrelimab · Drug: Cabazitaxel · Drug: Docetaxel · Drug: Apalutamide · Drug: Enzalutamide · Drug: Darolutamide · Drug: Abiraterone acetate plus prednisone (AAP) · Drug: Lutetium Lu-177 vipivotide tetraxetan · Drug: JNJ-101556143

Interventions

• DrugPasritamig

  Pasritamig will be administered.

  Also known as: JNJ-78278343

• DrugCetrelimab

  Cetrelimab will be administered by intravenous infusion.

  Also known as: JNJ-63723283

• DrugCabazitaxel

  Cabazitaxel will be administered by intravenous infusion.

• DrugDocetaxel

  Docetaxel will be administered by intravenous infusion.

• DrugApalutamide

  Apalutamide will be administered orally.

• DrugEnzalutamide

  Enzalutamide will be administered orally.

• DrugDarolutamide

  Darolutamide will be administered orally.

• DrugAbiraterone acetate plus prednisone (AAP)

  Abiraterone acetate plus prednisone (AAP) will be administered orally.

• DrugLutetium Lu-177 vipivotide tetraxetan

  Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.

• DrugJNJ-101556143

  JNJ-101556143 will be administered orally.

Primary outcomes

1. 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.

   Time frame: Up to 21 days after first dose of combination agent

2. 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.

   Time frame: Up to 2 years 11 months

Secondary outcomes

1. 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.

   Time frame: Up to 2 years 11 months

2. 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.

   Time frame: Up to 2 years 11 months

3. 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 frame: Up to 2 years 11 months

4. 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.

   Time frame: Up to 2 years 11 months

5. Duration of Response (DOR)

   DOR is defined for participants who achieved response (PR or better) as the time between the date of initial documentation of response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3, or death due to any cause, whichever occurs first.

   Time frame: Up to 2 years 11 months

6. Part 2H Metastatic hormone-sensitive prostate cancer (mHSPC) Participants : Composite Progression-Free Survival (PFS)

   Composite PFS is defined as time from start of treatment to the date of first occurrence of investigator determined disease progression (Response Evaluation Criteria in Solid Tumors \[RECIST\] or bone progression), pain, PSA progression, death or last disease assessment.

   Time frame: Up to 2 years 11 months

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu