NCT06115902已完成1 期
A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.20 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2023年11月17日最近更新:
适应症
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
- 153
- 试验地点
- 20
- 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), an 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 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast 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
- •Subjects voluntarily participate in this study and sign informed consent;
- •Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
- •Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure;
- •Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;
- •At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
- •The main organs function are normally;
- •Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.
排除标准
- •Concomitant disease and medical history:
- •Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
- •Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
- •Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
- •Long-term unhealed wounds or fractures;
- •Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;
- •Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
- •Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
- •Patients with any severe and/or uncontrolled disease;
- •Tumor related symptoms and treatment:
- •Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug;
- •Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment;
- •Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding;
- •Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
- •Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded;
- •Patients with severe bone injury due to tumor bone metastasis;
- •Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;
- •Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;
- •In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.
研究组 & 干预措施
TQB2102 for injection
Experimental
Dose: 6.0 mg/kg or 7.5 mg/kg of TQB2102 for injection. Administration: 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 10 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 14 months.)
- Overall Survival (OS)(Baseline up to 20 months.)
- Small molecule toxin(0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.)
- Disease Control Rate (DCR)(Baseline up to 10 months.)
- Clinical Benefit Rate (CBR)(Baseline up to 14 months.)
- Concentration of TQB2102(0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.)
- Concentration of total antibody(0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.)
- Progression-Free Survival (PFS)(Baseline up to 14 months.)
- Incidence 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 Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, 30 days after the end of the last infusion. Each cycle is 21 days.)
- 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.)
研究者
研究点 (20)
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