NCT05293028Unknown1 期
Phase I Clinical Study of Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of F527 in the Treatment of Patients With Relapsed or Refractory Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- DLTs
研究概览
简要总结
This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥18 and ≤80 years old;
- •Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
- •Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm);
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
- •Expected survival period ≥ 3 months;
- •The function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose):
- •Blood routine: neutrophil count ≥1.5×109/L; platelet count ≥75×109/L; hemoglobin ≥95g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: creatinine≤1.5×ULN; Coagulation function: International Normalized Ratio (INR)≤1.5×ULN and Activated Partial Thromboplastin Time (APTT)≤1.5×ULN;
- •Understand the test procedures and content, and sign the informed consent voluntarily.
排除标准
- •Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.;
- •Patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.);
- •History of hemolytic anemia or Evans syndrome in the last three months;
- •Positive direct antiglobulin test;
- •Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past;
- •Received anti-tumor-related treatments such as anti-tumor chemotherapy, radiotherapy, biological therapy, or immunotherapy/immunomodulation therapy within 2 weeks before the first administration; the toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except for alopecia);
- •Patients who have a history of organ transplantation or allogeneic bone marrow transplantation, or who have received autologous stem cell transplantation within 3 months before the first administration or have other severe immunodeficiency;
- •HIV positive patients, syphilis-infected patients (RPR positive and TPPA positive) or active hepatitis (HBsAg positive and/or HBcAb positive, and HBV-DNA positive or higher than the upper limit of normal; HCV antibody positive and HCV- RNA positive or above the upper limit of normal);
- •Patients with uncontrollable or severe cardiovascular disease, who have New York Heart Association (NYHA) class II or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; Uncontrolled hypertension (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥100mmHg);
- •Patients who have received any other clinical trial drug treatment within 4 weeks before the first dose;
- •Patients who have received live attenuated vaccine within 4 weeks before the first dose;
- •Patients who have a history of severe allergies, or who are known to be allergic to macromolecular protein preparations/monoclonal antibodies and any components of the investigational drug;
- •Patients with a history of mental illness or drug abuse;
- •Pregnant or lactating women, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and are reluctant to use a medically recognized effective contraceptive method (such as an intrauterine device or an intrauterine device) during the trial. condoms);
- •Patients who are judged by the investigator to be unsuitable for enrollment.
研究组 & 干预措施
Drug:F527
Experimental
F527 is dose-escalated sequentially by accelerated titration and i3+3 design.
干预措施: F527 (Drug)
结局指标
主要结局
DLTs
时间窗: Up to 21 days
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Maximum Tolerated Dose (MTD)
时间窗: Up to 21 days
Maximum Tolerated Dose
RP2D
时间窗: Up to 21 days
PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc.
次要结局
未报告次要终点
研究者
研究点 (1)
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