A Phase 1b/2, Open-Label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of SNB-101, in Extensive Stage Small Cell Lung Cancer.
The purpose of the Phase 1 research is to test the safety, tolerability, maximum tolerated dose, and pharmacokinetics (PK- the study of how a medicine moves through subject body. It looks at how the drug is absorbed, travels in your blood, reaches different parts of subject body, and is eventually broken down and removed) of the SNB-101.The Phase 2 is to determine the optimal dose (amount of medicine that works best to treat a condition while causing the fewest side effects) of SNB-101 for further research and to collect a further information on PK, safety and tolerability. Once subject has completed assessments during screening and if subject is found eligible to participate in the study, study drug will be given by intravenous infusion on day 1 and day 15 of each cycle treatment. Throughout the treatment period, the study doctor will monitor subject for any changes to subject health. While subject is taking the study drug, we will ask subject the following: * How subject are feeling. * If subject has experienced any side effects. * If subject is taking other medications or if there are changes to the medications subject was taking before. The study drug will be taken over multiple cycles. A cycle is the time between the start of 1 round of treatment until the start of the next round. In this study, each treatment cycle is of 28 days.
• Male or female patients over 18 years of age.
• Male or fertile female patients who have agreed to comply with effective contraceptive methods as required by this protocol and the specified contraceptive period.
• Participants must have a cytologically or histologically confirmed small cell lung cancer which is locally advanced or metastatic and has progressed on or after standard therapy for advanced disease containing platinum-based therapy plus etoposide with or without atezolizumab or durvalumab immunotherapy and is not suitable for complete surgical resection.
• Have measurable or evaluable disease consistent with RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1
• With life expectancy more than 12 weeks
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
• Have adequate hematological, renal, and liver function as defined by the following (lab test can be repeated during screening):
• Have recovered to grade 1 or better to (CTCAE version 5.0) from any reversible side effects of previous treatments. Note: Grade 2 alopecia and Grade 2 sensory neuropathy are not exclusionary.
• No major surgery, no antineoplastic or experimental therapy, and no direct radiation therapy to a hematopoietic site within 4 weeks prior to baseline, and no biologic drugs, nitrosoureas or mitomycin C administered within 6 weeks prior to baseline.
⁃ Fully informed regarding the investigational nature of the study protocol and is capable of signing an Institutional Review Board/Ethics Committee-approved informed consent form.