NCT07623707尚未招募1 期
An Open-Label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-B901 Injection as Monotherapy and in Combination With Standard or Investigator-Determined Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
研究概览
简要总结
FG-B901 is a recombinant humanized IgG2 bispecific antibody targeting PD-L1 and CD40. It is designed to provide PD-L1-dependent CD40 agonism, thereby enhancing selectivity for the tumor microenvironment and reducing systemic toxicity compared with conventional CD40 agonists. Preclinically, FG-B901 promotes antigen-presenting cell activation and synergizes with PD-L1/PD-1 blockade to potentiate T-cell anti-tumor immunity. This is an open-label, multicenter phase I/II trial in subjects with unresectable locally advanced or metastatic solid tumors. The primary objectives are to evaluate the safety, tolerability, and pharmacokinetics of FG-B901 as monotherapy and in combination with chemotherapy. Secondary objectives include preliminary anti-tumor efficacy (e.g., objective response rate, disease control rate, progression-free survival, and overall survival).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
- •Age 18-75 years (inclusive), any gender;
- •Have histologically or cytologically confirmed locally advanced or metastatic solid tumors, and have failed standard therapy, or are intolerant to standard therapy, or for whom standard therapy is not available;
- •Able to provide tumor tissue specimens and peripheral blood samples that meet testing requirements, or provide prior test reports that meet the requirements;
- •ECOG performance status of 0 or 1;
- •Expected survival ≥3 months;
- •Have at least one measurable tumor lesion according to RECIST 1.1 criteria;
- •Adequate cardiac, bone marrow, liver, renal function;
排除标准
- •Have received a live vaccine within 3 months prior to randomization;
- •Have received radiotherapy within 4 weeks prior to randomization;
- •Have received other anti-tumor drug therapy within 4 weeks or within 5 half-lives of the anti-tumor drug prior to randomization;
- •Have undergone major surgery within 4 weeks prior to randomization;
- •Have received any clinical study drug treatment within 4 weeks prior to randomization;
- •Have undergone major surgery within 4 weeks prior to randomization;
- •Have a history of other (non-study tumor) malignancies within 3 years prior to randomization;
- •Have received any organ transplant or bone marrow transplant;
- •Have previously received any tumor necrosis factor receptor (TNFR) agonist antibody therapy, such as anti-CD40, anti-OX40, anti-CD137, anti-CD27, anti-CD357 antibodies, etc;
- •Have experienced Grade ≥3 immune-related adverse events (irAEs) from prior immunotherapy;
- •Have a history of severe allergic reactions or are allergic to the investigational drug (FG-B901);
- •Have a history of central nervous system metastases and/or carcinomatous meningitis;
- •Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to randomization;
- •Have a history of severe respiratory disease;
- •Have experienced a clinically significant cardiac disease within 6 months before the first dose of study drug;
- •Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;
- •The investigator judges the subject to have obvious active gastrointestinal bleeding;
- •Known history of Hepatitis C or chronic active Hepatitis B;
- •Have experienced systemic treatment with corticosteroids within ≤2 weeks prior to randomization;
- •Any other condition of the subject (e.g., psychological, geographical, or medical condition) that does not permit compliance with the study and follow-up procedures;
- •Are pregnant or breastfeeding;
研究者
研究点 (1)
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