Recruiting
Phase 3

BNT324

Sponsor:

BioNTech SE

Code:

NCT07365995

Conditions

Metastatic Castration-resistant Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BNT324

Docetaxel

Prednisone/prednisolone

Study Details

Brief summary:

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 \[OS\]).

Conditions

Metastatic Castration-resistant Prostate Cancer

Study ID

NCT07365995

Start date

Apr 22, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2031

Anticipated

Primary completion date

Feb, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

736 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BNT324

active comparator: Docetaxel plus prednisone/ prednisolone

Interventions

BNT324

Intravenous infusion

Docetaxel

Intravenous infusion

Prednisone/prednisolone

Oral

Primary outcome measure

  • rPFS assessed by BICR [ Time Frame: From randomization to end of study, i.e., up to 58 months ]
  • OS [ Time Frame: From randomization to end of study, i.e., up to 58 months ]

Central Contacts and Locations

Central contacts

BioNTech clinical trials patient information

+49 6131 9084patients@biontech.de

Locations

Rocky Mountain Cancer Centers

Recruiting

Aurora, Colorado, United States, 80012

Florida Cancer Specialists- Fort Myers

Recruiting

Fort Myers, Florida, United States, 33901

Florida Cancer Specialists- St. Petersburg

Recruiting

St. Petersburg, Florida, United States, 33701

Florida Cancer Specialists- West Palm Beach

Recruiting

West Palm Beach, Florida, United States, 33401

Illinois Cancer Specialists

Recruiting

Niles, Illinois, United States, 60714

Illinois CancerCare PC

Recruiting

Peoria, Illinois, United States, 61615

Maryland Oncology Hematology

Recruiting

Rockville, Maryland, United States, 20850

White Plains Hospital

Recruiting

White Plains, New York, United States, 10601

Oncology/Hematology Care, Inc.

Recruiting

Cincinnati, Ohio, United States, 45242

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology South Austin

Recruiting

Austin, Texas, United States, 78731

Texas Oncology Gulf Coast

Recruiting

Houston, Texas, United States, 77024

Texas Oncology, P.A. - Tyler

Recruiting

Tyler, Texas, United States, 75702

Texas Oncology - West Texas

Recruiting

Wichita Falls, Texas, United States, 76310

Virginia Cancer Specialists PC

Recruiting

Fairfax, Virginia, United States, 22031

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

BioNTech SE

Last update posted

Sep 2, 2026

Last verified

Sep, 2026

Keywords

  • Immunotherapy
  • Antibody-drug conjugate (ADC)
  • Standard of care (SoC)
  • Chemotherapy
  • Steroids
  • BNT324 (DB-1311)
  • mCRPC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioNTech SE on 2026-09-02.