NCT06052423撤回2 期
ARTEMIS-007: A Phase 2 Study to Evaluate Efficacy and Safety of HS-20093 in Patients With Extensive Stage Small Cell Lung Cancer
Hansoh BioMedical R&D Company0 个研究点开始时间: 2024年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 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
This is a phase 2,open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with small cell lung cancer(SCLC).
详细描述
Intravenous (IV) administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and disease progression.
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
- •At least age of 18 years at screening.
- •Pathologically diagnosed as ES-SCLC; no prior systemic therapy for ES-SCLC.
- •At least one measurable lesion according to RECIST 1.
- •Agree to provide fresh or archival tumor tissue and peripheral blood samples.
- •ECOG PS of 0~
- •Life expectancy >= 12 weeks.
- •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
- •Treatment with any of the following:
- •Previous or current treatment with B7-H3 targeted therapy
- •Radiotherapy with a limited field of radiation for palliation within 2 weeks, 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-
- •Pleural or peritoneal effusion or pericardial effusion requiring clinical intervention.
- •Major surgery within 4 weeks prior to the first dose of HS-
- •Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
- •Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
- •Spinal cord compression or brain metastases.
- •CNS metastases with symptomatic or active progression.
- •Patients with tumor invasion of surrounding vital organs and blood vessels, at risk of esophagotracheal or esophagopleural fistula.
- •Any unresolved toxicities from prior therapy greater than Grade 2 according to CTCAE 5.
- •History of other primary malignancies.
- •Inadequate bone marrow reserve or organ dysfunction
- •Evidence of cardiovascular risk.
- •Severe, uncontrolled or active cardiovascular diseases.
- •Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
- •Severe or poorly controlled hypertension.
- •Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 month prior to the first dose of HS-20093
- •Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
- •Severe infections occurred within 4 weeks before the first dose.
- •Patients who have received continuous glucocorticoid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation.
- •The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
- •Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
- •Other moderate or severe lung diseases.
- •Previous history of serious neurological or mental disorders.
- •Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- •Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093
- •History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
- •Hypersensitivity to any ingredient of HS-
- •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
HS-20093
Experimental
All subjects will receive HS-20093 at 10mg/kg
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 or withdrawal from study, which ever came first, assessed up to 18 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
- Incidence and severity of adverse events (AEs)(From the first dose through 90 days post end of treatment)
- Observed maximum plasma concentration (Cmax) of HS-20093(From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days))
- Percentage of participants with antibodies to HS-20093 in serum(From pre-dose to 90 days post end of treatment)
- Progression-free survival (PFS) determined by investigators according to RECIST 1.1(From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 18 months)
- Overall survival (OS)(From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 18 months)
- Disease control rate (DCR) determined by investigators according to RECIST 1.1(From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 18 months)
- Duration of response (DoR) determined by investigators according to RECIST 1.1(From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 18 months)
- Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose in participants with advanced solid tumor(From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days))
- Terminal half-life (T1/2) of HS-20093 following IV dose in participants with advanced solid tumor(From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days))
- Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093(From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days))
研究者
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