SNB-101 for Treatment of 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 remov
| Condition(s) | Patient is Not Suitable for Complete Surgical Resection With a Cytologically or Histologically Confirmed Small Cell Lung Cancer(SCLC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. Through |
| Who can participate | Inclusion Criteria: 1. Male or female patients over 18 years of age. 2. Male or fertile female patients who have agreed to comply with effective contraceptive methods as required by this protocol and the specified contraceptive period. 3. 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. 4. Have measurable or evaluable disease consistent with RECIST (Response Evaluation Criteria in Solid Tumors) version 1.1 5. With life expectancy more than 12 weeks 6. Patients with Eastern Cooperative O |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | SN BioScience |
| Locations | Kamenitz, Serbia |
| Start date | 2026-03 |
| NCT ID | NCT07391813 |
| Official listing | https://clinicaltrials.gov/study/NCT07391813 |