NCT05823246招募中2 期
A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 66
- 试验地点
- 6
- 主要终点
- (part 1)Dose-limiting toxicity(DLT)
研究概览
简要总结
This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
详细描述
This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participated and signed a written informed consent form
- •Age ≥ 18 years, male or female
- •ECOG performance status of 0 or 1
- •Expected life-expectancy ≥ 3 months
- •Histologically confirmed diagnosis of locally advanced or metastatic unresectable melanoma or urothelial carcinoma, failed or intolerant or rejected to standard therapy
- •Patients must have at least one measurable lesion according to RECIST v1.1
- •Adequate organ function prior to QLF31907 administration
- •All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 180 days after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose.
排除标准
- •Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- •Known to be allergic to any excipients of QLF31907 or a history of severe allergic reactions to other monoclonal antibodies
- •Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or autologous stem cell transplantation within 180 days
- •Known history of cytotherapy or antitumor vaccine or other antitumor therapy or surgical treatment of main organs within 4 weeks
- •Known history of systemic glucocorticoid therapy or other immunosuppressants within 14 days
- •Active central nervous system (CNS) metastases
- •Known history of other active malignant tumor within 3 years, unless completely cured
- •With uncontrolled or clinically symptomatic pleural, pericardial or abdominal effusions
- •An active infectious disease requiring intravenous antibiotic therapy
- •Failure to recover to grade 1 from adverse reactions due to prior treatment according to CTCAE v5.0
- •An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
- •Known history of active hepatitis B/C infection, severe cardiovascular and cerebrovascular disease, idiopathic pulmonary fibrosis, pneumoconiosis, asbestosis, hepatitis (nonalcoholic steatohepatitis, alcoholic or autoimmune hepatitis), cirrhosis, active tuberculosis, active syphilis, HIV infection
- •Poorly controlled respiratory, circulatory or endocrine diseases
- •Known history of drugs abuse, alcoholism, neurologic or psychiatric disorders
- •Patients who are breastfeeding
- •Other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who are not suitable for participation in this study in the opinion of the investigator
研究组 & 干预措施
QLF31907
Experimental
single arm with QLF31907
干预措施: QLF31907 (Drug)
结局指标
主要结局
(part 1)Dose-limiting toxicity(DLT)
时间窗: 28days
(part 2) Objective response rate(ORR)
时间窗: up to 2 years
次要结局
- (part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)(up to 2 years)
- (part 2) Overall survival(OS)(up to 2 years)
- (part 2) Progression-free survival(PFS)(up to 2 years)
- (part 2) Maximum observed plasma concentration (Cmax)(up to 2 years)
- (part 2) Positive rate of anti-drug antibody(ADA)(up to 2 years)
研究者
研究点 (6)
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