NCT06929195已完成1 期
Phase I Clinical Trial Evaluating the Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB2210 Injection in Subjects With Advanced Malignant Tumors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.7 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年5月16日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 7
- 主要终点
- Dose Limiting Toxicity (DLT)
研究概览
简要总结
TQB2210 injection is a humanized monoclonal antibody against FGFR2b, which can bind to FGFR2b with high specificity and inhibit tumor growth by blocking the signaling pathway mediated by fibroblast growth factor receptor. The aim of this experiment is to evaluate the tolerability, pharmacokinetics, and preliminary efficacy of TQB2210 injection in patients with advanced malignant tumors, and to assess its effectiveness and phase II recommended dose (RP2D) in advanced malignant tumors with FGFR2b overexpression, such as advanced gastric/gastroesophageal junction cancer.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG-PS), score: 0-1; The expected survival time is more than 3 months.
- •At least one tumour lesion that can be evaluated according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 in the dose-escalation phase and at least one measurable lesion in the dose-expansion phase.
- •Good function of major organs.
- •Patients with advanced malignant tumours confirmed by histology or cytology, disease progression or intolerance after adequate standard treatment, lack of standard treatment options.
- •Can provide tumor tissue specimens collected fresh or sliced within 6 months (preserved in wax blocks collected within 3 years) for further detection for FGFR2b expression
- •Fertile subjects should agree that contraception must be used during the study and for 6 months after the end of the study; Women of childbearing age had a negative serum pregnancy test within 7 days prior to study enrollment and had to be non-lactating subjects.
- •Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
排除标准
- •Has had or is currently suffering from other malignant tumors
- •There are diseases that affect intravenous injection and venous blood collection
- •Adverse reactions from previous treatments have not recovered to CTCAE v5.0 Grade 1
- •Received major surgical treatment, significant traumatic injury within 4 weeks prior to the first dose of TQB2210, or exist long-term unhealed wounds or fractures
- •Subjects who experience any bleeding or bleeding events ≥ CTCAE grade 3 within 4 weeks prior to the first dose of TQB2210
- •An arterial/venous thrombotic event occurred within 6 months prior to to the first dose of TQB2210
- •Patients with active viral hepatitis that is poorly controlled
- •Active syphilis patients requiring treatment
- •A history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonitis/radiation pneumonia requiring treatment or active pneumonia with obvious clinical symptoms, interstitial pneumonia requiring treatment
- •Subjects with any severe and/or uncontrolled illnesses
- •Individuals who are preparing for or have previously undergone allogeneic bone marrow transplantation or solid organ transplantation
- •History of hepatic encephalopathy
- •Suffering from significant cardiovascular disease
- •Active or uncontrolled severe infections
- •Patients with renal failure requiring hemodialysis or peritoneal dialysis;
- •Corneal defects, corneal ulcers, keratitis or keratoconus, history of corneal transplantation, or other known corneal abnormalities that may increase the risk of developing corneal ulcers within 6 months prior to the first treatment or currently present
- •History of retinal disease or retinal detachment, or increased risk of retinal detachment according to the opinion of an ophthalmologist
- •Acute ophthalmic diseases that continue to progress within the first 4 weeks of enrollment
- •Unwilling to avoid using contact lenses during research treatment
- •History of immunodeficiency, includingHuman Immunodeficiency Virus（HIV） positivity or other acquired or congenital immunodeficiency diseases
- •There are poorly controlled autoimmune diseases that require the use of immunosuppressants or systemic hormone therapy to achieve immunity Subjects who inhibit the purpose and need to continue using it within 7 days before the first administration
- •Individuals with epilepsy who require treatment
- •Poor control of diabetes
- •Tumor related symptoms and treatment:
- •Received chemotherapy, immunotherapy, small molecule targeted drugs, etc. within 3 weeks before the first administration;
- •Traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA )approved drug directions within 1 week before the first drug use;
- •Imaging (Computed Tomography or Magnetic Resonance Imaging) shows that the tumor has invaded important blood vessels, or the researcher has determined that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
- •Uncontrolled pleural effusion, pericardial effusion, or moderate to severe ascites that still require repeated drainage;
- •Known to have spinal cord compression, meningeal metastasis/malignant meningitis, accompanied by symptoms of brain metastasis, or symptoms/imaging control time less than 4 weeks. Within 2 weeks before the start of treatment, steroid therapy or dehydration agents are still required;
- •For non-small cell lung cancer subjects known to have meaningful gene mutations such as epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) fusion, ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS) fusion, etc., they should have received corresponding targeted therapy;
- •Subjects with known human epidermal growth factor receptor 2 (HER2) positive gastric/gastroesophageal junction cancer and breast cancer should have received corresponding anti HER2 treatment;
- •Known to be allergic to research drug excipient components
- •Previously received targeted FGFR2b monoclonal antibod therapy
- •Previously received chemotherapy drugs used in the protocol (limited to subjects receiving combination therapy during the dose escalation phase only)
- •Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to their first medication.
- •According to the judgment of the researchers, there are situations that seriously endanger the safety of the subjects or affect their ability to complete the study
研究组 & 干预措施
TQB2210 Injection
Experimental
Dose escalation experiment:
Intravenous infusion once of TQB2210 for injection every two weeks, 28 days as one treatment cycle.
(1.0 mg/kg, 3.0 mg/kg, 8.0 mg/kg, 16.0 mg/kg, 24.0 mg/kg)
Dose expansion experiment:
Chose one or two appropriate dose groups in the dose escalation experiment to amplify.
干预措施: TQB2210 Injection (Drug)
结局指标
主要结局
Dose Limiting Toxicity (DLT)
时间窗: During the first cycle. Each cycle is 28 days
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI CTCAE v5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle(28 days) of treatment.
Maximum tolerated dose (MTD)
时间窗: During the first cycle. Each cycle is 28 days
MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Recommended Phase II Dose
时间窗: During the first cycle. Each cycle is 28 days
The recommended dosage for subsequent Phase II studies will be based on MTD (Maximum Tolerant Dose), pharmacokinetics, preliminary efficacy and safety comprehensively determined.
Objective Response Rate (ORR) (dose expansion phase)
时间窗: Up to 2 years
Defined as the percentage of Complete Response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
次要结局
- Adverse event rate(Up to 2 years)
- Objective Response Rate (ORR) (dose escalation phase)(Up to 2 years)
- Disease control rate (DCR)(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
- Progress Free Survival (PFS)(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Pharmacokinetics: The area under the curve (AUC)(2 hours pre-dose, 0,2,6,24,48,72,120,168 hours after dose on cycle1 day1 and cycle3 day1; 2 hours pre-dose on cycle1 day15 and cycle3 day15, each cycle is 28 days.)
- Pharmacokinetics:Peak concentration (Cmax)(2 hours pre-dose, 0,2,6,24,48,72,120,168 hours after dose on cycle1 day1 and cycle3 day1; 2 hours pre-dose on cycle1 day15 and cycle3 day15, each cycle is 28 days.)
- Pharmacokinetics: T1/2(2 hours pre-dose, 0,2,6,24,48,72,120,168 hours after dose on cycle1 day1 and cycle3 day1; 2 hours pre-dose on cycle1 day15 and cycle3 day15, each cycle is 28 days.)
- Pharmacokinetics: Apparent Clearance (CL/F)(2 hours pre-dose, 0,2,6,24,48,72,120,168 hours after dose on cycle1 day1 and cycle3 day1; 2 hours pre-dose on cycle1 day15 and cycle3 day15, each cycle is 28 days.)
- Pharmacokinetics: Vss/F(2 hours pre-dose, 0,2,6,24,48,72,120,168 hours after dose on cycle1 day1 and cycle3 day1; 2 hours pre-dose on cycle1 day15 and cycle3 day15, each cycle is 28 days.)
- Immunogenicity: The incidence of drug-resistant antibodies (ADA) and neutralizing antibodies (NAb)(Cycle1 Day1, Cycle2 Day1, Cycle6 Day1; Cycle12 Day1: pre-dose 120 minutes; At the end of treatment visit (EOT) 30 days after the end of the infusion. Each cycle is 28 days.)
研究者
研究点 (7)
Loading locations...
相似试验
招募中
2 期
A Clinical Trial of TQB2102 for Injection in Gynecological Tumors With Recurrent/Metastatic AdvancedNCT06798207Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.170
招募中
2 期
A Clinical Trial of TQB2102 for Injection in Non-small Cell Lung Cancer With HER2 Gene AbnormalityNon-Small Cell Lung CancerNCT06496490Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.270
Unknown
1 期
Clinical Trial of the TQB2930 Injection in Patients With Advanced CancersAdvanced CancersNCT05380882Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.60
已完成
1 期
A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast CancerBreast CancerNCT06115902Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.153
进行中（未招募）
1 期
Clinical Trial of the TQB2102 Injection in Patients With Advanced CancersAdvanced CancerNCT05735496Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.219