Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 800
- 试验地点
- 360
- 主要终点
- Progression Free Survival (PFS) for Arm A vs Arm B
研究概览
简要总结
This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.
详细描述
The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have received no more than 2 prior lines of therapy in advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be approximately 700 eligible participants.
During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15 in 28-day cycle (Arm B).
This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participants' quality of life.
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
- Single (Outcomes Assessor)
盲法说明
Open label
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
- •Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression.
- •Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
- •A WHO/ECOG performance status of 0 or 1 at Screening.
- •Has radiographically measurable disease by RECIST 1.1
排除标准
- •include but are not limited to the following:
- •Had uterine sarcomas or uterine neuroendocrine carcinoma.
- •Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.
- •Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs .
- •Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.
- •History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
- •Active or previously documented autoimmune or inflammatory disorders
研究组 & 干预措施
Puxitatug Samrotecan
Puxi-Sam IV (intravenous) Q3W .
干预措施: Puxitatug Samrotecan (Drug)
Chemotherapy
Physician's choice of chemotherapy
Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
干预措施: Doxorubicin (Drug)
Chemotherapy
Physician's choice of chemotherapy
Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival (PFS) for Arm A vs Arm B
时间窗: Approximately 3 years
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Overall survival (OS) for Arm A vs Arm B
时间窗: Approximately 3 years
OS is defined as the time from randomization until the date of death due to any cause.
次要结局
- Assessment of Overall Response Rate (ORR) for Arm A vs Arm B(Approximately 3 years)
- Assessment of Duration of response (DoR) for Arm A vs Arm B(Approximately 3 years)
- Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B(Approximately 3 years)
- Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B(Approximately 3 years)
- Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B(Approximately 3 years)
- Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B(Approximately 3 years)
- Worsening in endometrial symptoms for Arm A vs Arm B(Approximately 3 years)