NCT04236362Unknown1 期
A Phase Ib, Single Arm, Open-label Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Gynecological Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer，34 endometrial cancer，22 cervical 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understood and signed an informed consent form;
- •18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;
- •Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;
- •Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4 cycles of platinum-containing treatment) after tumor reduction, and meet any of the following：Platinum-resistant or refractory patients, including patients who have progressed or relapsed during previous platinum-containing chemotherapy regimens or within 6 months after the end of platinum-containing chemotherapy;
- •At least one measurable lesion according to the RECIST 1.1;
- •The main organs function are normally;
- •Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.
排除标准
- •Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
- •Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
- •Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;
- •Has received bevacizumab within 28 days before the first dose;
- •Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks;
- •Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;
- •Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose> 10mg / day prednisone or other effective hormones) and continue to use it within 2 weeks before the first dose;
- •Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
- •Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;
- •Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
- •Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before the first dose;
- •Has clinically significant thyroid dysfunction before the first dose;
- •Has multiple factors affecting oral medication;
- •Has any severe acute complications before the first dose;
- •Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;
- •According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.
研究组 & 干预措施
TQB2450+Anlotinib
Experimental
TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: TQB2450 (Drug)
TQB2450+Anlotinib
Experimental
TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
干预措施: Anlotinib (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 96 weeks
Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)
次要结局
- Disease control rate（DCR）(up to 96 weeks)
- Progression free survival (PFS)(up to 96 weeks)
- Duration of Response (DOR)(up to 96 weeks)
- Overall Survival (OS)(up to 120 weeks)
研究者
研究点 (5)
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