A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 684
- 主要终点
- Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
研究概览
简要总结
This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years of age
- •Has histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization.
- •Has a life expectancy of at least 4 months.
- •Has adequate organ function
排除标准
- •Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma.
- •Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy,
- •Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix] with no evidence of metastatic disease.
- •Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization,
- •Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose.
- •Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV)
- •Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed
- •Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration [30 days or longer]).
- •Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload
研究组 & 干预措施
Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
干预措施: Prednisolone (Drug)
Risvutatug rezetecan (Ris-Rez)
Participants will receive Risvutatug rezetecan (Ris-Rez).
干预措施: Risvutatug rezetecan (Ris-Rez) (Biological)
Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
干预措施: Enzalutamide (Drug)
Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
干预措施: Prednisone (Drug)
Standard of Care
Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone).
干预措施: Abiraterone (Drug)
结局指标
主要结局
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
时间窗: Up to approximately 169 weeks
rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.
Overall Survival (OS)
时间窗: Up to approximately 169 weeks
OS is defined as the time from randomization to date of death by any cause.
次要结局
- Time to Pain Progression (TTPP)(Up to approximately 169 weeks)
- rPFS by Investigator assessment(Up to approximately 169 weeks)
- Confirmed Objective Response Rate (cORR)(Up to approximately 169 weeks)
- Duration of Response (DoR)(Up to approximately 169 weeks)
- Time to Prostate-specific antigen (PSA) progression(Up to approximately 169 weeks)
- Prostate-specific antigen 50 (PSA50) response(Up to approximately 169 weeks)
- Time to first Symptomatic Skeletal-Related Event (SSRE)(Up to approximately 169 weeks)
- Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity(Up to approximately 169 weeks)
- Number of participants with AEs leading to dose modifications or study intervention discontinuation(Up to approximately 169 weeks)
- Serum concentration of Ris-Rez (conjugated antibody and payload)(Up to approximately 84 days)
- Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez(Up to approximately 169 weeks)
- Titers of ADA against Ris-Rez(Up to approximately 169 weeks)
- Participant-reported experience on study treatment(Up to approximately 169 weeks)