PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Evaluate safety of Olvi-Vec in patients from day 1 to end of study
研究概览
简要总结
Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC
详细描述
Olvi-Vec is a genetic engineering modification of acne virus. GLP preclinical studies include the safety, pharmacology, and toxicology have been completed. Clinical studies exploring efficacy and safety in different types of tumor are ongoing.
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
- •Able to understand and voluntarily sign an informed consent form.
- •Age ≥ 18 years old, gender not limited.
- •Small cell lung cancer confirmed by organization or cytology.
- •After receiving platinum based chemotherapy regimens and/or immunotherapy, platinum based chemotherapy regimens and/or anlotinib, and other recommended treatments according to guidelines, disease progression or recurrence has occurred.
- •There should be at least one measurable target lesion during the baseline period, according to RECIST 1.1 (if a lesion that has received radiation therapy has obvious evidence of disease progression after radiation therapy, it can be used as a target lesion).
- •ECOG physical condition score 0 or
- •Have sufficient bone marrow, liver and kidney organ function-
排除标准
- •Compound small cell lung cancer and transformed small cell lung cancer.
- •Patients with brain metastases and neurological symptoms; Note: Subjects with previous imaging evidence of brain metastases who have undergone local treatment (such as radiotherapy or surgery) for intracranial metastases and have stable lesions for more than 28 days without symptoms can be enrolled.
- •Other primary malignant tumors other than small cell lung cancer (excluding non melanoma skin cancer, breast cancer in situ, cervical cancer in situ, and superficial bladder cancer, or other cancers that have been effectively controlled in the past three years and have no evidence of disease recurrence) were previously or currently combined.
- •Clinically significant cardiovascular diseases At the beginning of the study treatment, the toxicity associated with previous anti-tumor treatments did not recover to ≤ CTCAE grade 1, except for hair loss and peripheral neurotoxicity of CTCAE grade
- •Known HIV infection (HIV antibody positive), active hepatitis B and C patients.
- •Receive chemotherapy, targeted therapy, radiotherapy, and biological therapy, with less than 4 weeks since the first administration in this study; Or have received local radiotherapy within 2 weeks.
- •Having undergone major surgery or significant traumatic injury within 28 days prior to the first administration of the investigational drug -
研究组 & 干预措施
Experimental
Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate.
干预措施: Olvi-Vec (Drug)
Experimental
Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate.
干预措施: platinum (cisplatin or carboplatin) (Drug)
Experimental
Olvi-Vec will be administered for 3 days in C1, then starting from C2, platinum (platinum (cisplatin or carboplatin)) and episode are administrated each 21 days till patients could not tolerate.
干预措施: Etoposide (Drug)
结局指标
主要结局
Evaluate safety of Olvi-Vec in patients from day 1 to end of study
时间窗: Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.
Frequency and severity of adverse events measured according to NCI Common Toxicity Criteria Adverse Event (CTCAE), version 5.0
次要结局
- Explore the dose limiting toxicity (DLTs) during day 1 to day 25 of treatment cycle 1(Day 1 to day 25 of treatment cycle 1)
- Objective Response Rate (ORR)(Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.)
- Disease control rate (DCR)(Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.)
- Progression free survival (PFS)(Interval between the date of enrollment and the date of withdraw and completion of study, up to a maximum of 2 years.)