N
← Back to Search
Sponsored

Accelerate Your Clinical Trial Recruitment

Reach thousands of high-intent patients matching your specific inclusion criteria.

Start Campaign
RECRUITING Phase 3 ClinicalTrials.gov

A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer

Sponsor: BioNTech SE • ClinicalTrials.gov ID: NCT07365995

Registry updated: 2026-10-16
Ad

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Check Eligibility →

Description

This study will test whether BNT324 is safe and works better against metastatic castration-resistant prostate cancer (mCRPC) than the current standard of care (SoC) chemotherapy, which is docetaxel (given together with the steroid medicines prednisone or prednisolone). The study will include participants with mCRPC that have been previously treated with androgen receptor pathway inhibitor, but with no previous taxane-based systematic chemotherapy for mCRPC. The main goals of this study are: * To find out if BNT324 helps participants live longer without their cancer getting worse (radiographic progression-free survival \[rPFS\]). * To find out if BNT324 helps participants live longer overall (overall survival \[OS\]).

Interventions

  • BNT324 (Drug)
    Intravenous infusion
  • Docetaxel (Drug)
    Intravenous infusion
  • Prednisone/prednisolone (Drug)
    Oral

Eligibility criteria

Key Inclusion Criteria: * Are male adults (defined as ≥18 years of age or of an acceptable age according to local regulations at the time of giving informed consent). * Must have documented progressive prostate cancer based on at least one of the following criteria: * Serum/plasma PSA progression, by local laboratory, defined as two consecutive increases in PSA over a previous reference value, each measured sequentially at least 1 week apart. The PSA value at screening is required to be ≥1.0 ng/mL. * Radiographic soft tissue progression as per PCWG3-modified RECIST v1.1. * Radiographic progression of bone disease: evaluable disease or new bone lesion(s) by bone scan per PCWG3 criteria. * Had previously received one or two prior androgen receptor pathway inhibitor treatments and experienced disease progression during or after a minimum of 8 weeks of therapy. * Must not have received systemic cytotoxic chemotherapy, including taxane-based chemotherapy, for mCRPC. * Must have had prior orchiectomy and/or have ongoing androgen-deprivation therapy and a castrate-level of serum/plasma testosterone (\<50 ng/dL or \<1.7 nmol/L). Participant being treated with luteinizing hormone-releasing hormone agonists or antagonists must continue such treatment throughout the study. * Must have an Eastern Cooperative Oncology Group performance score of 0 or 1. Key Exclusion Criteria: * Have received prior treatment with B7-H3 targeted therapy, including B7-H3 ADCs. * Have uncontrolled or significant cardiovascular disease, as defined in the protocol. * Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids or have current ILD/pneumonitis. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Conditions

Metastatic Castration-resistant Prostate Cancer

Locations

  • Sansum Clinic — Santa Barbara, California, United States
  • Rocky Mountain Cancer Centers — Aurora, Colorado, United States
  • Florida Cancer Specialists- Fort Myers — Fort Myers, Florida, United States
  • Florida Cancer Specialists- St. Petersburg — St. Petersburg, Florida, United States
  • Florida Cancer Specialists- West Palm Beach — West Palm Beach, Florida, United States
  • Piedmont Cancer Institute — Atlanta, Georgia, United States
  • Illinois Cancer Specialists — Niles, Illinois, United States
  • Illinois CancerCare PC — Peoria, Illinois, United States
  • Maryland Oncology Hematology — Rockville, Maryland, United States
  • NYOH Albany Cancer Center — Albany, New York, United States
  • White Plains Hospital — White Plains, New York, United States
  • Oncology/Hematology Care, Inc. — Cincinnati, Ohio, United States
  • START Carolinas — Myrtle Beach, South Carolina, United States
  • SCRI Oncology Partners — Nashville, Tennessee, United States
  • Tennessee Oncology — Nashville, Tennessee, United States
  • Texas Oncology South Austin — Austin, Texas, United States
  • Texas Oncology Gulf Coast — Houston, Texas, United States
  • Texas Oncology, P.A. - Tyler — Tyler, Texas, United States
  • Texas Oncology - West Texas — Wichita Falls, Texas, United States
  • Virginia Cancer Specialists PC — Fairfax, Virginia, United States
  • Virginia Oncology Associates — Norfolk, Virginia, United States
  • Tasman Onco Research Pty Ltd — Southport, Australia
  • Cliniques Universitaires Saint-Luc — Brussels, Belgium
  • Peking University First Hospital — Beijing, China
  • Beijing Cancer Hospital — Beijing, China
  • The First Affiliated Hospital of Hunan Normal University — Changsha, China
  • West China Hospital, Sichuan University — Chengdu, China
  • The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China
  • Fujian Medical University Union Hospital — Fuzhou, China
  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University — Hangzhou, China
  • Zhejiang Cancer Hospital — Hangzhou, China
  • Second Hospital of Anhui Medical University — Hefei, China
  • The First Affiliated Hospital of Nanchang University — Nanchang, China
  • Nanjing Drum Tower Hospital — Nanjing, China
  • Shanghai Cancer Center — Shanghai, China
  • No. 10 People's Hospital of Shanghai — Shanghai, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, China
  • Hubei Cancer Hospital — Wuhan, China
  • Yijishan Hospital of Wannan Medical College — Wuhu, China
  • Yantai Yuhuangding Hospital — Yantai, China
  • Universitätsklinikum Carl Gustav Carus — Dresden, Germany
  • Asklepios Klinik Altona — Hamburg, Germany
  • Pratia MCM Krakow — Krakow, Poland
  • National Research Institute of Oncology - National Research Institute (NIO-PIB) — Warsaw, Poland
  • Addenbrooke's Hospital — Cambridge, United Kingdom
  • Velindre Cancer Centre — Cardiff, United Kingdom
  • St James's University Hospital — Leeds, United Kingdom
  • Royal Marsden Hospital — London, United Kingdom
  • Freeman Hospital — Newcastle upon Tyne, United Kingdom
  • Southampton General Hospital — Southampton, United Kingdom
  • Royal Marsden Hospital — Sutton, United Kingdom
Sponsored

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record