No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
736 (estimated)
Sponsor
BioNTech SE · Industry
Who this trial is looking for
This trial is looking for men with advanced prostate cancer that has not responded to certain previous treatments. Participants will compare a new treatment called BNT324 to the standard chemotherapy treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have advanced prostate cancer that is worsening.
I have had previous treatment with androgen receptor pathway inhibitors.
I have not received chemotherapy for my prostate cancer.
I have had surgery to remove my testicles or am on hormone therapy.
I have a low level of testosterone.
I have a good performance status score.
You may not be able to join if
I have received treatment targeting B7-H3.
I have uncontrolled heart disease.
I have a history of lung issues that required steroids.
I have current lung issues.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 wit…
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 \[OS\]).
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 progressio…
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.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.