BNT324 versus docetaxel for metastatic castration-resistant prostate cancer
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
PHASE3 · BioNTech SE · NCT07365995
This trial will test whether BNT324, an antibody‑drug conjugate immunotherapy, works better than standard chemotherapy (docetaxel plus prednisone or prednisolone) for men with metastatic castration‑resistant prostate cancer who have had prior androgen‑receptor pathway inhibitors but no prior taxane chemotherapy for mCRPC.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 736 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | BioNTech SE (industry) |
| Drugs / interventions | chemotherapy, prednisone |
| Locations | 5 sites (Rockville, Maryland and 4 other locations) |
| Trial ID | NCT07365995 on ClinicalTrials.gov |
What this trial studies
This is a randomized, phase III trial that assigns participants 1:1 to receive either BNT324 or docetaxel with prednisone/prednisolone in 21‑day treatment cycles. Key eligibility includes men with progressive mCRPC after one or two androgen‑receptor pathway inhibitors and no prior taxane chemotherapy for mCRPC. The co‑primary endpoints are radiographic progression‑free survival (rPFS) and overall survival (OS), with tumor scans reviewed by a blinded independent central review (BICR). Treatment continues until disease progression, unacceptable toxicity, withdrawal, or study end, with safety monitoring by an independent committee and follow‑up planned for up to about 58 months per participant.
Who should consider this trial
Good fit: Ideal candidates are adult men with metastatic castration‑resistant prostate cancer who progressed after one or two androgen‑receptor pathway inhibitors and who have not received prior taxane‑based chemotherapy for mCRPC and who meet routine clinical and lab eligibility criteria.
Not a fit: Patients who have already received taxane chemotherapy for mCRPC, who have major organ dysfunction or other exclusionary comorbidities, or who cannot tolerate the study treatments are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, BNT324 could extend the time before cancer gets worse and improve overall survival compared with current docetaxel chemotherapy, offering a new treatment option.
How similar studies have performed: Antibody‑drug conjugates and other targeted immunotherapies have shown promise in several cancers and early‑phase prostate cancer studies, but large phase III evidence in mCRPC is still limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rockville, Maryland and 4 other locations
- Maryland Oncology Hematology — Rockville, Maryland, United States (RECRUITING)
- SCRI Oncology Partners — Nashville, Tennessee, United States (RECRUITING)
- Texas Oncology South Austin — Austin, Texas, United States (RECRUITING)
- Texas Oncology Gulf Coast — Houston, Texas, United States (RECRUITING)
- Texas Oncology, P.A. - Tyler — Tyler, Texas, United States (RECRUITING)
Study contacts
- Study coordinator: BioNTech clinical trials patient information
- Email: patients@biontech.de
- Phone: +49 6131 9084
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Castration-resistant Prostate Cancer, Immunotherapy, Antibody-drug conjugate, Standard of care, Chemotherapy, Steroids, BNT324, mCRPC