NCT05154630终止1 期
Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2858 Injection in Subjects With Advanced Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 5
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This study is divided into two phases: dose escalation and cohort expansion. The dose escalation stage aims to evaluate the tolerability, pharmacokinetic characteristics and safety of TQB2858 injection in subjects with advanced malignant tumors. The cohort expansion phase aims to evaluate the initial efficacy and safety of TQB2858 injection in patients with soft tissue sarcoma, and to explore treatment-related biomarkers.
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
- •Phase I (dose-escalation phase).
- •a) Patients with advanced malignant solid/hematologic tumors who have a histologically and/or cytologically confirmed diagnosis and who have failed standard therapy or lack effective therapies.
- •Phase II (cohort expansion phase).
- •Unresectable, recurrent or metastatic adenoid soft tissue sarcoma diagnosed by histology.
- •Previously received anti-vascular targeted drug therapy
- •Have at least one measurable lesion Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
- •Age: 18 to 70 years old;
- •The Eastern Cooperative Oncology Group (ECOG) score: 0 to 1;
- •The expected survival period is ≥3 months;
- •Normal function of major organs
- •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.
- •Patients voluntarily enroll in this study, sign an informed consent form and comply well.
排除标准
- •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:
- •Tumor-related symptoms and treatment:
- •Have received surgery, chemotherapy, radiotherapy or other anti-cancer 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.
- •Prior receipt of immune dual anti-treatment drugs against the same target of TQB2858 injection.
- •Uncontrolled pleural effusions, pericardial effusions, or ascites that still require repeated drainage (in the judgment of the investigator);
- •Brain metastases with less than 4 weeks of stable symptom control after discontinuation of dehydrating agents and steroids.
- •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.
- •Participation in other clinical trials of antineoplastic drugs within 4 weeks prior to enrollment.
- •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
Participants will receive 3 mg/60 mg/600 mg/1200 mg/1800 mg single dose of TQB2858 injection on Day 1, iv (injection of vein), once every three 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
ORR 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 iRECIST (CR and PR under iRECIST criteria can occur after imaging disease progression).
Maximum tolerated dose (MTD)
时间窗: Baseline up to 48 weeks
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD.
次要结局
- Progression-Free Survival (PFS)(up to 48 weeks)
- Duration of Response (DOR)(up to 48 weeks)
- Disease control rate（DCR）(up to 48 weeks)
- Overall survival (OS)(Baseline up to die)
研究者
研究点 (5)
Loading locations...
相似试验
尚未招募
1 期
A Clinical Trial of TQB3117 Tablets in Patients With Advanced Malignant CancerAdvanced Malignant CancerNCT06415903Chia Tai Tianqing Pharmaceutical Group Co., Ltd.59
招募中
1 期
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Neuroendocrine Carcinoma.Neuroendocrine CarcinomaNCT06440057Suzhou Zelgen Biopharmaceuticals Co.,Ltd78
招募中
1 期
Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung CancerNeuroendocrine CancerSmall Cell Lung CancerNCT06283719Suzhou Zelgen Biopharmaceuticals Co.,Ltd265
已完成
1 期
A Clinical Trial of TQB3006 Tablets in Patients With Advanced Malignant CancerAdvanced Malignant NeoplasmNCT06344351Chia Tai Tianqing Pharmaceutical Group Co., Ltd.27
撤回
1 期
A Clinical Trial of TQB3015 Tablets in Patients With Advanced Malignant CancerAdvanced Malignant NeoplasmNCT06165809Chia Tai Tianqing Pharmaceutical Group Co., Ltd.