RecruitingPhase 1Phase 2NCT07391813

SNB-101 for Treatment of Extensive Stage Small Cell Lung Cancer

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.


Sponsor

SN BioScience

Enrollment

55 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called SNB-101 in people with extensive-stage small cell lung cancer (SCLC) — an aggressive form of lung cancer that has spread beyond one lung — that has come back or worsened after standard chemotherapy and immunotherapy. **You may be eligible if...** - You are 18 or older - You have been diagnosed with small cell lung cancer (confirmed by biopsy) that is locally advanced or has spread - Your cancer has progressed after platinum-based chemotherapy (with etoposide, with or without atezolizumab or durvalumab) - You cannot have the cancer fully removed by surgery - You have at least one measurable tumor on imaging - Your expected survival is at least 12 weeks and your general health is reasonably good **You may NOT be eligible if...** - You have not yet received standard chemotherapy - You have uncontrolled brain metastases - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSNB-101

SNB-101 is a nanoparticle formulation of SN-38 administered intravenously. Subject enrolled for each dose level cohort of 50/80 mg/m2, 60/96 mg/m² and 70/112 mg/m2 will be administered intravenously over 90 minutes at Day 1 and Day 15 of each cycle


Locations(1)

The Institute for Pulmonary Diseases of Vojvodina

Kamenitz, Serbia

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NCT07391813