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

Trial status:Will Be Recruiting
Trial ID:
BNT324-03
NCT ID:
NCT07365995
EudraCT ID:
N/A
EU Trial (CTIS) Number:
2025-524445-27-00
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
BioNTech SE
Collaborator:
BioNTech Shanghai Pharmaceutical Co., Ltd., DualityBio Inc.
Will Be Recruiting

Trial Details

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 \[OS\]).
Medical Condition
  • Prostate Cancer
    • Study Drug
  • BNT324
    • See more
  • Docetaxel
  • Prednisone/prednisolone
    • Phase
    Phase 3
    Type
    Interventional
    Estimated Enrolment
    736
    Estimated Trial Date
    Mar 2026 - Feb 2031

    Trial Participant Requirements

    Age
    18+ years
    Sex
    Male
    Healthy Volunteers
    No
    Inclusion and Exclusion Criteria
    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.
    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.

    Trial Locations

    No locations found.