NCT04805060招募中1 期
A Phase I, Open-label, Dose Escalation Study to Evaluate the Tolerance and Pharmacokinetics of TQB2858 Injection in Subjects With Terminal Malignant Tumor
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This study is a phase I study to evaluate the safety and tolerability of TQB2858 injection in patients with advanced malignancy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced malignancies diagnosed histologically and/or cytologically, where standard treatment has failed or there is no effective treatment;
- •Age: 18-75 years old;
- •ECOG score: 0 ~ 1;
- •Expected survival of more than 3 months;
- •The main organs are functioning normally;
- •Women of childbearing age must be negative for serum or urine HCG within 7 days prior to study enrollment and must be non-lactating;Patients should agree to use contraception during the study period and for 6 months after the study period.
- •Patients voluntarily joined the study and signed the informed consent, showing good compliance.
排除标准
- •Complicated disease and history: A) Has developed other malignant tumors within 2 years or is currently suffering from the same tumor; B) unmitigated toxic reactions above CTC AE grade 1 due to any prior treatment, excluding hair loss and peripheral sensory nerve disorders; C) received major surgical treatment or significant traumatic injury (excluding needle biopsy) within 28 days prior to the commencement of study treatment; D) Long-term unhealed wounds or fractures; E) The occurrence of arterial/venous thrombosis events within 6 months, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism; F) People with a history of psychotropic substance abuse and inability to quit or with mental disorders; G) subjects with any severe and/or uncontrolled disease;"
- •Tumor-related symptoms and treatment: A) had undergone surgery, chemotherapy, radiation or other anticancer therapy within 4 weeks prior to the start of study treatment (washout period was calculated from the end of the last treatment); B) Chinese patent drugs with anti-tumor indications specified in the NMPA approved drug specifications (including compound cantharide capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Brucea oil injection/capsule, Xiaoaoping tablet/injection, Huabenin capsule, etc.) were received within 2 weeks before the start of the study; C) previously received immunodouble antibody therapy targeting the same target of TQB2858 injection; D) uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator); E) Patients with brain metastases whose symptoms stabilized less than 4 weeks after discontinuation of dehydrants and steroids;"
- •Research Treatment Related: A) a history of live attenuated vaccine vaccination within 28 days prior to the study treatment initiation or a planned live attenuated vaccine vaccination during the study period; B) Previous history of severe allergy to macromolecular drugs or known components of TQB2858 injection; C) Study the occurrence of active autoimmune disease requiring systemic treatment (e.g., use of palliative drugs, corticosteroids, or immunosuppressants) within 2 years prior to treatment initiation.Alternative therapies (such as thyroxine, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic; D) have been diagnosed with immunodeficiency or are receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy.(dose of >10mg/ day prednisone or other equivalent efficacy hormone), and continued to use within 2 weeks of the first administration;" Participants had participated in other antitumor drug clinical trials in the previous 4 weeks;
- •Subject who, in the Investigator's judgment, has a concomitant disease that seriously endangers the subject's safety or affects the completion of the study, or is considered unsuitable for inclusion for other reasons.
研究组 & 干预措施
TQB2858 injection
Experimental
TQB2858 administered intravenously (IV) once every 3 week
干预措施: TQB2858 injection (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Each subject started from the signing of the informed consent until 30 days after the last administration or the start of a new target indication
The incidence of all adverse events (AE), serious adverse events (SAE) and treatment-related adverse events (TEAEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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