NCT05262101终止2 期
Single-arm, Open-label, Multicenter Phase Ib Clinical Trial of TQB2858 Injection in the Treatment of Advanced High-grade Sarcoma
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2022年5月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study is a single-arm, open-label, multicenter Phase Ib clinical trial evaluating TQB2858 injection in the treatment of advanced high-grade sarcoma. To evaluate the preliminary efficacy and safety of TQB2858 injection in patients with advanced high-grade sarcoma, and to explore the relevant biomarkers of TQB2858 injection.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 Histologically confirmed unresectable, recurrent or metastatic high-grade sarcoma;
- •2 Received at least first-line therapy before, disease progression or intolerance during treatment, or disease progression after treatment; (excluding alveolar soft tissue sarcoma and clear cell sarcoma)
- •Cohort 1: newly treated acinar soft tissue sarcoma;
- •Cohort 2: Acinar soft tissue sarcoma with failed PD-1 therapy;
- •Cohort 3: Other subtypes (pleomorphic sarcoma, classic osteosarcoma, Ewing sarcoma, chondrosarcoma, dedifferentiated liposarcoma, etc.).
- •3 Age: 18 to 70 years old;
- •4 The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
- •5 The expected survival period is ≥3 months;
- •6 Normal function of major organs
- •7 Women of childbearing age should agree to use effective contraceptive measures during the study period and 6 months after the end of the study, and have a negative serum or urine pregnancy test within 7 days before enrollment in the study; men should agree to use effective contraception during the study period and after the end of the study period 6 Effective contraceptive measures must be used within one month.
- •8 Patients voluntarily enroll in this study, sign an informed consent form and comply well.
排除标准
- •1 Combined diseases and medical history:
- •Have presented with or currently have concurrent other malignancies within 2 years.
- •Unresolved toxic reactions due to any prior treatment above Common Terminology Criteria for Adverse Events (CTCAE) grade 1, excluding alopecia, peripheral sensory nerve disorders.
- •Major surgical treatment or significant traumatic injury within 28 days prior to the start of study treatment.
- •Long-term untreated wounds or fractures.
- •An arterial/venous thrombotic event within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism.
- •Persons with a history of psychotropic substance abuse who are unable to abstain or have a mental disorder.
- •Subjects with any severe and/or uncontrollable disease, including:
- •2 Tumor-related symptoms and treatment:
- •Received surgery, chemotherapy, radiotherapy, or other anticancer therapy within 4 weeks prior to the start of study treatment;
- •Treatment with proprietary Chinese medicines with clear antitumor indications in the National Medical Products Administration (NMPA)-approved drug formulary within 2 weeks prior to the start of study treatment.
- •Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage;
- •Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
- •3 Research and treatment related:
- •History of live attenuated vaccination within 28 days prior to the start of study treatment.
- •Prior history of severe allergy to macromolecular drugs or allergy to known components of TQB2858 injection.
- •Active autoimmune disease requiring systemic therapy that occurred within 2 years prior to the start of study treatment.
- •Diagnosis of immunodeficiency or being treated with systemic glucocorticoids or any other form of immunosuppressive therapy.
- •4 Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
- •5 Subjects who, in the judgment of the investigator, have a concomitant illness that seriously jeopardizes the safety of the subject or interferes with the completion of the study, or for whom other reasons are deemed to exist for ineligibility for enrollment.
研究组 & 干预措施
TQB2858 injection
Experimental
TQB2858 injection (1800mg intravenous(iv), on day 1 of every 3 weeks)
干预措施: TQB2858 injection (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: up to 48 weeks
Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST1.1 for immune based therapeutics (iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression).
次要结局
- Disease control rate (DCR)(up to 48 weeks)
- Overall survival (OS)(Baseline up to die)
- Progression-Free Survival (PFS)(up to 48 weeks)
- Duration of Response (DOR)(up to 48 weeks)
研究者
研究点 (1)
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