NCT06798207招募中2 期
A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent/Metastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.31 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年3月13日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 31
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent/metastatic advanced gynecological tumors.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects voluntarily participate in this study, sign informed consent and have good compliance.
- •The age is ≥ 18 years old (subject to the date of signing the informed consent); Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survival time ≥ 3 months ;
- •Histologically confirmed, unresectable recurrent / metastatic advanced gynecologic tumors;
- •The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue, and the subjects with completely negative IHC 0 staining are excluded.
- •Previous chemotherapy with platinum-based drugs was unsuccessful.
- •There is at least one measurable lesion according to the RECIST 1.1 criteria; women of childbearing potential need to meet the following conditions: the serum/urine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.
排除标准
- •Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously.
- •Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia.
- •Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before the start of treatment.
- •Long-term unhealed wounds or fractures.
- •Subjects with a history of interstitial lung disease/pneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currently accompanied by interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening imaging and cannot be excluded.
- •Subjects with moderate to severe pulmonary dysfunction/disease within 3 months before the first administration.
- •Arterial/deep vein thrombosis events occurred within 6 months before treatment, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.
- •Subjects with any severe and/or uncontrolled diseases.
- •Patients with local recurrence suitable for surgery or radiotherapy.
- •Those with disease progression after receiving chemotherapy drugs of topoisomerase I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment.
- •Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study.
- •Received treatment with Chinese patent medicines with clear anti-tumor indications in the drug instructions approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration in this study.
- •Serosal effusion that requires repeated drainage to relieve clinical symptoms, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment.
- •Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs.
- •Subjects with known central nervous system metastasis and/or carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may be considered for inclusion if clinically stable.
- •Severe bone damage and spinal cord compression caused by tumor bone metastasis, including weight-bearing bone pathological fractures that occurred within 6 months or are likely to occur in the near future, poorly controlled severe bone pain, etc.
- •Those allergic to macromolecular drug components or allergic to any research drug, any component or excipient in the drug.
- •Received live attenuated vaccines within 4 weeks before treatment.
- •Active autoimmune diseases that required systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration.
- •Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.
研究组 & 干预措施
TQB2102 for injection
Experimental
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle
干预措施: TQB2102 for injection (Drug)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Baseline up to 12 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR)
次要结局
- Duration of remission (DOR)(Baseline up to 12 months)
- Progression-free survival (PFS)(Baseline up to 12 months)
- Overall survival (OS)(Baseline up to 17 months)
- Frequency of adverse event (AE)(From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first)
- Disease control rate (DCR)(Baseline up to 12 months)
- Severity of adverse event (AE)(From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.)
- Anti-drug antibody (ADA)(Before infusion on cycle1 day1, cycle2 day1,cycle 4 day1, cycle7 day1, cycle12 day1 (each cycle is 21 days), 30 days after the end of the last infusion)
研究者
研究点 (31)
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