A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Recruiting · NCT07365995 · Interventional (participants receive a specific treatment) · Lead sponsor: BioNTech SE
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 \[OS\]).
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 it is running
30 locations listed across 9 US states.
- Rocky Mountain Cancer Centers - Aurora, Colorado, United States
- Florida Cancer Specialists- Fort Myers - Fort Myers, Florida, United States
- Florida Cancer Specialists- St. Petersburg - St. Petersburg, Florida, United States
- Florida Cancer Specialists- West Palm Beach - West Palm Beach, Florida, United States
- Illinois Cancer Specialists - Niles, Illinois, United States
- Illinois CancerCare PC - Peoria, Illinois, United States
- Maryland Oncology Hematology - Rockville, Maryland, United States
- White Plains Hospital - White Plains, New York, United States
- Oncology/Hematology Care, Inc. - Cincinnati, Ohio, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Texas Oncology South Austin - Austin, Texas, United States
- Texas Oncology Gulf Coast - Houston, Texas, United States
- Texas Oncology, P.A. - Tyler - Tyler, Texas, United States
- Texas Oncology - West Texas - Wichita Falls, Texas, United States
- Virginia Cancer Specialists PC - Fairfax, Virginia, United States
- Virginia Oncology Associates - Norfolk, Virginia, United States
- Addenbrooke's Hospital - Cambridge, United Kingdom
- The First Affiliated Hospital of Hunan Normal University - Changsha, China
- The Second Affiliated Hospital of Chongqing Medical University - Chongqing, China
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University - Hangzhou, China
- Zhejiang Cancer Hospital - Hangzhou, China
- Royal Marsden Hospital - London, United Kingdom
- The First Affiliated Hospital of Nanchang University - Nanchang, China
- Shanghai Cancer Center - Shanghai, China
- Royal Marsden Hospital - Sutton, United Kingdom
- The First Affiliated Hospital of Wenzhou Medical University - Wenzhou, China
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Wuhan, China
- Hubei Cancer Hospital - Wuhan, China
- Yijishan Hospital of Wannan Medical College - Wuhu, China
- Yantai Yuhuangding Hospital - Yantai, China