NCT07296341招募中1 期
A Phase IB/II Study To Evaluate the Safety, Tolerability, and Preliminary Efficacy of HRS-4642 Combination With Other Antitumor Therapies in Patients With Solid Tumors
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
This study is a randomized, open-label, multicenter Phase II clinical trial designed to evaluate the Safety, Tolerability and Preliminary Efficacy of HRS-4642 Combination with Other Antitumor Therapies in Patients with Solid Tumors
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range of 18-75 years old (inclusive of both ends), gender not limited when signing the informed consent form
- •ECOG performance status 0 or 1
- •Life expectancy of greater than or equal to 12 weeks.
- •Subjects with unresectable local advanced or metastatic pancreatic cancer, and pancreatic duct adenocarcinoma confirmed by histopathology
- •Provide tumor tissue blocks fixed in formalin, embedded in paraffin, or unstained tumor specimen sections, which can be archived or freshly obtained within 3 years prior to the first study treatment (fresh acquisition is preferred).
- •At least one measurable lesion is present according to the efficacy evaluation criteria for pancreatic cancer (RECIST 1.1)
排除标准
- •Accompanied by untreated or active central nervous system (CNS) tumor metastasis
- •Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria
- •Subjects known or suspected to have interstitial pneumonia
- •According to the common adverse reaction event evaluation criteria NCI-CTCAE v5.0, patients with ≥ grade 3 serous fluid accumulation or imaging evidence of a large amount of abdominal fluid accumulation (those who require therapeutic puncture and drainage within 2 weeks before starting the study treatment, only those with imaging showing a small amount of ascites and no clinical symptoms can be enrolled)
- •Acute or chronic pancreatitis with significant clinical significance
研究组 & 干预措施
HRS-4642 combination with Adebrelimab Injection, nab-paclitaxel in combination with gemcitabine
Experimental
干预措施: HRS-4642;Adebrelimab Injection; nab-paclitaxel; gemcitabine (Drug)
nab-paclitaxel in combination with gemcitabine
Active Comparator
干预措施: HRS-4642;nab-paclitaxel; gemcitabine (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: From the date of first dose of study drug until progressive disease (PD), death, whichever occurs first, assessed up to 16 months
PFS is defined as the time from the date of first dose of study drug to the date of the first documentation of disease progression or date of death, whichever occurs first.
次要结局
- Objective response rate (ORR)(up to 10 months following the date the last patient was randomized)
- disease control rate (DCR)(up to 10 months following the date the last patient was randomized)
- Duration of response (DoR)(up to 10 months following the date the last patient was randomized)
- Overall survival (OS)(From study start until target OS events have occurred (approximately 20 months after last patient enrollment))
研究者
研究点 (1)
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