2025-524445-27-00招募中3 期
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- BioNTech SE
- 入组人数
- 211
- 试验地点
- 58
- 主要终点
- Per arm. OS is defined as time from randomization to death from any cause.
研究概览
简要总结
To assess the efficacy of BNT324 compared to docetaxel for radiographic progression-free survival (rPFS) as assessed by blinded independent central review (BICR) per prostate Cancer Working Group 3 (PCWG3)-modified response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria in participants with mCRPC. To assess the efficacy of BNT324 compared to docetaxel for overall survival (OS) in participants with mCRPC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
- •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 androgendeprivation 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
排除标准
- •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.
研究组 & 干预措施
PREDNISONE
Comparator
干预措施: PREDNISONE (Drug)
BNT324
Test
干预措施: BNT324 (Drug)
DOCETAXEL
Comparator
干预措施: DOCETAXEL (Drug)
结局指标
主要结局
Per arm. OS is defined as time from randomization to death from any cause.
Per arm. OS is defined as time from randomization to death from any cause.
Per arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first.
Per arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first.
次要结局
- Per arm. TFST is defined as time from randomization to initiation of the first subsequent systemic anticancer therapy or death, whichever occurs first.
- Per arm. ORR is defined as the proportion of participants in whom a confirmed complete response (CR) or partial response (PR) (per PCWG3-modifed RECIST v1.1 as assessed by BICR) is observed as best overall response.
- Per arm. DOR is defined as time from first objective response (confirmed CR or PR per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) to first occurrence of objective tumor progression (progressive disease per PCWG3-modified RECIST v1.1 criteria as assessed by BICR) or death from any cause, whichever occurs first.
- Per arm. TTPP is defined as time from randomization to pain progression as determined by Brief Pain Inventory-Short Form Item 3 “worst pain in 24 hours” and opiate analgesic use (Analgesic Quantification Algorithm score).
- Per arm. rPFS is defined as time from randomization to radiographic disease progression per PCWG3-modified RECIST v1.1 criteria, or death from any cause, whichever occurs first.
- By arm. Time to first SSRE is defined as time from randomization to first occurrence of any of the following SSREs: - Use of external beam radiation therapy to prevent or relieve skeletal symptoms. - New symptomatic pathologic bone fracture (vertebral or non-vertebral). - Spinal cord compression. - Tumor-related orthopedic surgical intervention.
- Per arm. Time to PSA progression is defined as time from randomization to PSA progression per PCWG3 criteria.
- Per arm. PSA response is defined as having a post-baseline PSA reduction ≥50% from baseline with a consecutive confirmation assessment at least 3 weeks later per PCWG3 criteria.
- Per arm, from the start of trial treatment until 30 days after the last dose of trial treatment or until start of new systemic anticancer therapy, whichever occurs first: - Occurrence of TEAEs including Grade ≥3, serious, and fatal TEAEs by relationship. - Occurrence of dose interruptions, reductions or discontinuations of trial treatment due to TEAEs.
研究者
Clinical Trial Information Desk
Scientific
BioNTech SE
研究点 (58)
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