NCT06227546进行中（未招募）2 期
A Phase II Study of MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
The goal of this clinical trial is to test MGC018 in patients with relapsed or refractory Extensive-Stage Small-Cell Lung Cancer (ES-SCLC). The main question it aims to answer is:
• Does the administration of MGC018 achieve a clinically meaningful response rate of 25% in patients with relapsed or refractory ES-SCLC?
Participants enrolled in the trial will receive MGC018 through an intravenous (IV) infusion, every 28 days until disease progression or unacceptable toxicity. Tumor assessment will be done every 2 cycles (28 day cycles). Blood samples will be taken for biomarker analysis before treatment, on cycle 3 day 1, and at progression. A pretreatment biopsies will be done.
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
- •1. Age greater than or equal to 18 years at time of signing Informed consent form (ICF)
- •2. Ability to comply with the study protocol, in the investigator's judgment.
- •3. Histologically or cytologically confirmed advanced small cell lung cancer that is not amenable to definitive therapy. Patients with epidermal growth factor receptor (EGFR)-mutant Non Small Cell Lung Cancer (NSCLC) that has transformed to Small Cell Lung Cancer (SCLC) will be allowed if their SCLC has progressed following treatment with platinum-based chemotherapy.
- •4. Disease progression during or following treatment with platinum-based chemotherapy.
- •a) Patients could have received any number of therapies for relapsed or progressive disease.
- •5. Measurable disease per RECIST v1.1
- •6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •7. Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment:
- •1. Absolute Neutrophil Count (ANC) greater than or equal to (\>/=) 1.0 x 10\^9/L (1000/uL) without granulocyte colony-stimulating factor support
- •2. Platelet count \>/=100 x 10\^9/L (100,000/uL) without transfusion
- •3. Hemoglobin \>/= 80 g/L (8 g/dL) (1) Patients may be transfused to meet this criterion.
- •4. Aspartate Aminotransferase (AST), Alanine Transaminase (ALT), and alkaline phosphatase (ALP) less than or equal to (\/= 30 mL/min (calculated using the Cockcroft-Gault formula)
- •7. For patients not receiving therapeutic anticoagulation: international normalized ratio (INR) and Partial Thromboplastin Time, Activated (aPTT) \/= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.
- •3. Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
- •4. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
- •11. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:
- •1. With a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \< 1% per year during the treatment period and for 90 days after the final dose of MGC018. Men must refrain from donating sperm during this this same period.
- •2. With a pregnant female partner, men must remain abstinent or use a condom during the treatment period and 90 days after the final dose of MGC018 to avoid potential exposure to the embryo.
- •3. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.
排除标准
- •Patients with treated brain metastases are eligible if they are symptomatically stable while off steroid therapy for a minimum of 7 days
- •History of leptomeningeal disease
- •Patient who are receiving any other investigational agents
- •Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •Diagnosis of another malignancy. However, patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- •Evidence of pleural and/or pericardial effusion. A small and/or asymptomatic effusion is not exclusionary.
- •Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the view of the investigator, contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications.
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 6 months after the final dose of study treatment.
研究组 & 干预措施
MCG018
Experimental
干预措施: MGC018 (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 1 year
Investigator-Assessed ORR per Response Evaluation Criteria In Solid Tumors (RECIST v1.1) for target lesions as assessed by CT or magnetic resonance imaging (MRI) scans (with IV contrast unless contraindicated) of the chest, abdomen, and pelvis every 2 cycles (each cycle is a 28 day cycle). Reported as the number of patients with a complete response (CR) or partial response (PR); ORR = CR+PR; CR = Disappearance of all target lesions.Any pathological lymph nodes (whether target ornon-target) must have reduction in short axis to\<10 mm. PR= At least a 30% decrease in the sum ofdiameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Overall Survival (OS)(3 years)
- Incidence of Adverse Events(from start of treatment through 60 days after last treatment, approximately 1 year)
- Duration of response (DOR)(1 year)
- Progression-free survival (PFS) Median(1 year)
- Progression-free survival (PFS) 6 months(6 months)
- Duration of Response (DOR)(1 year)
- Progression-free Survival (PFS) Median(1 year)
- Progression-free Survival (PFS) 6 Months(6 months)
研究者
研究点 (2)
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