A Phase III Trial of BNT324 Versus Docetaxel in Metastatic Castration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorBioNTech SE
About this trial
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 \[OS\]).
Eligibility criteria
Qualifiers
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).
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- BNT324
- Docetaxel
- Prednisone/prednisolone
Treatment groups
736 Participants
are divided into 2 treatment groupsSponsors and collaborators
BioNTech SE
Lead sponsor
BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Collaborator
DualityBio Inc.
Collaborator
Source ClinicalTrials.gov