ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer

Part of paid clinical trials in La Jolla, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04662580
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Metastatic Prostate Cancer

Eligibility Criteria

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

Interventions

  • ARX517 — DRUG
    ARX517 is an ADC consisting of a humanized anti-PSMA monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two (2) proprietary microtubule-disrupting toxins referred to as AS269.
  • Apalutamide — DRUG
    Oral tablet and will be given once daily by mouth.
  • Abiraterone acetate — DRUG
    Oral tablet and will be given once daily by mouth.
  • Prednisone — DRUG
    Oral tablet and will be given once daily in metastatic castration-sensitive prostate cancer( mCSPC) and twice daily in metastatic castration-resistant prostate cancer (mCRPC) cohort by mouth.

Study Details

This is a phase 1 study to assess the safety and tolerability of ARX517 as monotherapy or combination therapy in adult subjects with metastatic prostate cancer (mPC).

Key Dates

Start date
May 3, 2021
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
183 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARX517
    ARX517 will be administered via intravenous (IV) infusion, with the initial treatment regimen by weight-based infusion at an interval of every 3 weeks. Other treatment regimen may be explored.
  • Experimental: ARX517+Apalutamide
    ARX517 and apalutamide
  • Experimental: ARX517+AAP
    ARX517 and abiraterone acetate plus prednisone(AAP)

Primary Outcome Measure

Assess incidence of adverse events [ Time Frame: 1.5 Years ]

Locations (12)

FacilityCityStateZIPSite coordinators
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-
University of California, Los Angeles School of MedicineLos AngelesCalifornia90095-3000-
UCSF Medical Center at Mission BaySan FranciscoCalifornia94143-2350-
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-5116-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-5000-
Washington University St. Louis School Medicine Siteman Cancer CenterSt LouisMissouri63110-
GU Research NetworkOmahaNebraska68130-
Weill Cornell Medical CollegeNew YorkNew York10021-5663-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
University of WashingtonSeattleWashington98101-

Find similar trials in La Jolla, CA

By research site
UC San Diego Moores Cancer Center· La Jolla, CAUniversity of California, Los Angeles School of Medicine· Los Angeles, CAUCSF Medical Center at Mission Bay· San Francisco, CAWinship Cancer Institute of Emory University· Atlanta, GAIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, INUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MI

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