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

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05818683
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Castration-resistant Prostate Neoplasms
  • Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pasritamig — DRUG
    Pasritamig will be administered.
  • Cetrelimab — DRUG
    Cetrelimab will be administered by intravenous infusion.
  • Cabazitaxel — DRUG
    Cabazitaxel will be administered by intravenous infusion.
  • Docetaxel — DRUG
    Docetaxel will be administered by intravenous infusion.
  • Apalutamide — DRUG
    Apalutamide will be administered orally.
  • Enzalutamide — DRUG
    Enzalutamide will be administered orally.
  • Darolutamide — DRUG
    Darolutamide will be administered orally.
  • Abiraterone acetate plus prednisone (AAP) — DRUG
    Abiraterone acetate plus prednisone (AAP) will be administered orally.
  • Lutetium Lu-177 vipivotide tetraxetan — DRUG
    Lutetium Lu-177 vipivotide tetraxetan will be administered intravenously.
  • JNJ-101556143 — DRUG
    JNJ-101556143 will be administered orally.

Study Details

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 Dates

Start date
Apr 26, 2023
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
May 23, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Part 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: Up to 21 days after first dose of combination agent ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsSarasotaFlorida34232-
Start MidwestGrand RapidsMichigan49546-
Washington University School Of MedicineSt LouisMissouri63110-
Perlmutter Cancer Center at NYU Langone BrooklynBrooklynNew York11223-
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long IslandMineolaNew York11501-
NYU Langone HealthNew YorkNew York10016-
Sidney Kimmel Cancer Center - Jefferson HealthPhiladelphiaPennsylvania19107-

Find similar trials in Sarasota, FL

By research site
Florida Cancer Specialists· Sarasota, FLStart Midwest· Grand Rapids, MIWashington University School Of Medicine· St Louis, MOPerlmutter Cancer Center at NYU Langone Brooklyn· Brooklyn, NYLaura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island· Mineola, NYNYU Langone Health· New York, NY

Related Studies