NCT07232875招募中3 期
a Randomized, Controlled, Double-Blind, Multicenter Phase III Clinical Trial of HRS-4642 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as First-Line Therapy in Patients With Advanced or Metastatic Pancreatic Carcinoma Harboring KRAS G12D Gene Mutation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 588
- 试验地点
- 1
- 主要终点
- OS
研究概览
简要总结
This study investigates the first-line treatment of advanced pancreatic cancer with KRAS G12D mutation. Patients were randomized 1:1 to receive either the experimental regimen HRS-4642 plus AG or the control regimen AG alone.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able and willing to provide a written informed consent
- •Age 18-75 years old (inclusive) at the time of signing the informed consent form
- •Male or female
- •ECOG score of 0 or 1
- •Expected survival ≥ 12 weeks
- •At least one measurable lesion according to RECIST v1.1 criteria
排除标准
- •Any other condition that, in the judgment of the investigator, may increase the risk of participating in the study, interfere with the results of the study, or be unsuitable for participation in this study
- •Presence of uncontrollable psychiatric illness and other conditions such as known alcoholism, drug or substance abuse, criminal detention, etc., that affect the completion of the study procedures
- •Known hypersensitivity to any component of HRS-4642; History of severe allergic reactions to other monoclonal antibodies/fusion protein drugs; Known history of severe hypersensitivity to antineoplastic agents in combination
- •Received other major surgery other than diagnosis or biopsy within 28 days before the first dose; Minor traumatic surgery (biopsy, laparoscopy, and drainage) within 7 days prior to the first dose; Presence of non-healing wounds (severe, non-healing, or dehiscence), untreated fractures
- •Subjects who are participating in other clinical studies or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or who have 5 half-lives of this investigational drug, whichever is shorter
- •Use of a live attenuated vaccine within 28 days prior to the first dose of study medication, or anticipated need for a live attenuated vaccine during study treatment
- •Have a history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation
- •Those who have active pulmonary tuberculosis infection within 1 year before enrollment, or those who have a history of active pulmonary tuberculosis infection more than 1 year ago but have not been formally treated
- •Active hepatitis B
- •Presence of clinically significant acute or chronic pancreatitis
- •Poorly controlled or severe cardiovascular and cerebrovascular diseases, arterior/venous thrombotic events within 6 months prior to study entry
- •Presence of gastrointestinal obstruction or presence of symptoms and signs of gastrointestinal obstruction within 6 months prior to the start of study treatment, but screening can be performed if surgical treatment has been performed and the obstruction has been completely resolved
研究组 & 干预措施
HRS-4642 + AG
Experimental
干预措施: HRS-4642 + AG (Drug)
HRS-4642 placebo + AG
Active Comparator
干预措施: HRS-4642 placebo + AG (Drug)
结局指标
主要结局
OS
时间窗: up to 3 years
PFS as assessed by BICR per RECIST 1.1
时间窗: up to 2 years
次要结局
- ORR,as assessed by BICR per RECIST v1.1(up to 2 years)
- DCR as assessed by BICR per RECIST v1.1(up to 2 years)
- Incidence and severity of adverse events (AEs) graded by NCI-CTCAE v5.0.(Twice a month，up to 2 years)
- DoR as assessed by BICR per RECIST v1.1(up to 2 years)
- PFS as assessed by the investigator per RECIST v1.1.(up to 2 years)
- ORRas assessed by the investigator per RECIST v1.1.(up to 2 years)
- DCR as assessed by the investigator per RECIST v1.1.(up to 2 years)
- DoR as assessed by the investigator per RECIST v1.1.(up to 2 years)
研究者
研究点 (1)
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