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New hope for tough prostate cancer: BNT324 takes on chemo

NCT ID NCT07365995

Disease control Sponsor: BioNTech SE Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 5 times

Summary

This study tests a new drug called BNT324 against standard chemotherapy (docetaxel) in men with metastatic castration-resistant prostate cancer that has progressed after hormone therapy. The goal is to see if BNT324 helps patients live longer without their cancer worsening. About 736 men will participate in this Phase 3 trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BNT324 (also called DB-1311)
What this could lead to
If it works, BNT324 could offer a more effective treatment option for men with advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early-stage Phase 3 trial, so results are not guaranteed. The new drug may not work better than current chemotherapy and could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 736 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Feb 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castration resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Florida Cancer Specialists- Fort Myers

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists- St. Petersburg

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Florida Cancer Specialists- West Palm Beach

    RECRUITING

    West Palm Beach, Florida, 33401, United States

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, 430079, China

  • Illinois Cancer Specialists

    RECRUITING

    Niles, Illinois, 60714, United States

  • Illinois CancerCare PC

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Maryland Oncology Hematology

    RECRUITING

    Rockville, Maryland, 20850, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, 210008, China

  • Oncology/Hematology Care, Inc.

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Aurora, Colorado, 80012, United States

  • Royal Marsden Hospital

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sansum Clinic

    RECRUITING

    Santa Barbara, California, 93105, United States

  • Shanghai Cancer Center

    RECRUITING

    Shanghai, 200032, China

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, 310016, China

  • Tasman Onco Research Pty Ltd

    RECRUITING

    Southport, 4215, Australia

  • Texas Oncology - West Texas

    RECRUITING

    Wichita Falls, Texas, 76310, United States

  • Texas Oncology Gulf Coast

    RECRUITING

    Houston, Texas, 77024, United States

  • Texas Oncology South Austin

    RECRUITING

    Austin, Texas, 78731, United States

  • Texas Oncology, P.A. - Tyler

    RECRUITING

    Tyler, Texas, 75702, United States

  • The First Affiliated Hospital of Hunan Normal University

    RECRUITING

    Changsha, 410005, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, 330006, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, 325000, China

  • The Second Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, 400072, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, 420104, China

  • Virginia Cancer Specialists PC

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • White Plains Hospital

    RECRUITING

    White Plains, New York, 10601, United States

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, 264000, China

  • Yijishan Hospital of Wannan Medical College

    RECRUITING

    Wuhu, 241001, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, 310022, China

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