A Phase 2, Open-label, Multi-center Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of HS-20093 in Patients with Advanced Esophageal Carcinoma and Other Advanced Solid Tumors (ARTEMIS-005)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 21
- 主要终点
- Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
研究概览
简要总结
HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the anti-tumor activity, safety, pharmacokinetics and immunogenicity of HS-20093 in Chinese advanced esophageal carcinoma and other solid tumor patients.
详细描述
This is an open-label, multi-center phase 2 study in Chinese adult participants with recurrent, locally advanced or metastatic esophageal carcinoma or other advanced solid tumors, which is designed to investigate the efficacy, safety, pharmacokinetics and immunogenicity of HS-20093. This study will consist of two parts: phase IIa and phase IIb.
Part 1 (phase IIa) will conducted in participants with relapsed, locally advanced or metastatic esophageal carcinoma and other advanced solid tumor. Subjects will receive one dose levels of HS-20093 intravenously every 3 weeks.
Part 2 (phase IIb) will enroll participants with relapsed, locally advanced or metastatic esophageal squamous cell carcinoma. One dose levels of HS-20093 will be administered as an intravenous (IV) infusion every 3 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Men or women aged more than or equal to (≥) 18 years.
- •Histologically or cytologically confirmed, relapsed, locally advanced or metastatic esophageal carcinomas and other advanced solid tumor.
- •At least one extra measurable lesion according to RECIST 1.1 (cavity structures such as oesophagus cannot serve as measurable lesions).
- •Agree to provide fresh or archival tumor tissue and blood samples.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~
- •Estimated life expectancy >12 weeks.
- •Agree to use medically accepted methods of contraception.
- •Men or women should be using adequate contraceptive measures throughout the study.
- •Females subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- •Signed and dated Informed Consent Form.
排除标准
- •Any of the following would exclude the subject from participation in the study:
- •Treatment with any of the following:
- •Previous or current treatment with B7-H3 targeted therapy Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093 Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093 Local radiotherapy for palliation within 2 weeks of the first dose of study drug, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093 Major surgery within 4 weeks prior to the first scheduled dose of HS-20093
- •Subjects with previous or concurrent malignancies
- •Significant tumor invasion into adjacent organs (aorta or trachea) of esophageal lesions leading to higher risk of bleeding or fistula
- •Inadequate bone marrow reserve or organ dysfunction.
- •Evidence of cardiovascular risk
- •Evidence of current severe or uncontrolled systemic diseases
- •Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
- •Severe infections occured within 4 weeks before the first dose
- •The presence of active infectious diseases has been known before first dose such as hepatitis B, hepatitis C, ect
- •History of neuropathy or mental disorders
- •Pregnant or lactating female
- •History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093
- •Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093
- •Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator
- •Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
研究组 & 干预措施
Phase IIa: Cohort 1
Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.
干预措施: HS-20093 (Drug)
Phase IIa: Cohort 2
Participants with advanced esophageal adenocarcinoma and gastroesophageal junction adenocarcinoma will be administered HS-20093.
干预措施: HS-20093 (Drug)
Phase IIa: Cohort 3
Participants with other advanced solid tumor will be administered HS-20093.
干预措施: HS-20093 (Drug)
Phase IIb
Participants with advanced esophageal squamous cell carcinoma will be administered HS-20093.
干预措施: HS-20093 (Drug)
结局指标
主要结局
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
时间窗: From the first dose up to disease progression（PD）or withdrawal from study，whichever comes first，assessed up to 24 months.
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
次要结局
- Disease Control Rate (DCR) assessed by RECIST 1.1 criteria(From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months.)
- DOR assessed by RECIST 1.1 criteria(From the first dose up to PD or death, whichever came first, assessed up to 24 months.)
- PFS assessed by RECIST 1.1 criteria(From the first dose up to PD or death，whichever came first, assessed up to 24 months.)
- Overall survival (OS)(From the first dose up to PD or death，whichever came first, assessed up to 24 months.)
- Incidence and severity of adverse events(From the first dose until 90 days after the last dose)
- Characterize the pharmacokinetic parameters of HS-20093(Cycle 1 Day 1 up to 90 days after the last dose)
- Assess the incidence of anti-drug antibodies (ADAs)(Cycle 1 Day 1 up to 90 days after the last dose)