Actively Recruiting
SNB-101 for Treatment of Extensive Stage Small Cell Lung Cancer
Led by SN BioScience · Updated on 2026-03-09
55
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
SNB-101 for Treatment of Extensive Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients over 18 years of age
- Male or fertile female patients who agree to use effective contraceptive methods during the study
- Cytologically or histologically confirmed small cell lung cancer that is locally advanced or metastatic and progressed after standard platinum-based therapy plus etoposide with or without immunotherapy
- Measurable or evaluable disease consistent with RECIST version 1.1
- Life expectancy longer than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematological, renal, and liver function as defined by study lab tests
- Recovery to grade 1 or better from any reversible side effects of previous treatments (except grade 2 alopecia and sensory neuropathy)
- No major surgery, antineoplastic or experimental therapy, or radiation to hematopoietic sites within 4 weeks prior to baseline
- No biologic drugs, nitrosoureas, or mitomycin C within 6 weeks prior to baseline
- Fully informed and capable of signing informed consent
You will not qualify if you...
- Presence of homozygous or certain heterozygous UGT1A1 gene variants (Phase 1 only)
- Female patients who are pregnant, lactating, or planning pregnancy during the study
- Known intolerance or hypersensitivity to SNB-101 or its ingredients
- Deemed unsuitable or ineligible by the Principal Investigator
- Uncontrolled symptomatic heart failure
- History of alcohol or substance abuse within 1 year prior to screening
- Intestinal palsy or bowel obstruction
- Chronic inflammatory bowel disease
- On dialysis
- Current or prior interstitial lung disease or pneumonitis requiring high-dose steroids
- Clinically significant uncontrolled congestive heart failure
- Multiple ascites or pleural effusion
- Hematologic malignancy including lymphoma
- Severe or uncontrolled infections requiring antibiotics or antivirals
- QTc interval longer than 480 msec
- Positive for HIV
- Active hepatitis B or C infection
- Symptomatic central nervous system or brain metastases requiring systemic corticosteroids within 2 weeks prior to baseline
- Use of another investigational drug within 4 weeks prior to screening
- Requirement for additional anticancer therapy other than the investigational drug during the study (localized palliative radiation allowed)
- Recent surgery, radiation, chemotherapy, targeted therapy, immunotherapy, or hormone therapy
- Use of strong CYP3A4 inducers within 2 weeks before baseline
- Use of strong CYP3A4 or UGT1A1 inhibitors within 1 week before baseline
- Planned use of neuromuscular blockers during the study
- Planned use of lapatinib during the study
- Planned administration of live herbal medicine detoxified vaccines during the study
- Use of drugs significantly affecting liver metabolism or kidney excretion unless stopped 4 weeks prior to baseline
- Use of medications affecting investigational product efficacy or safety unless dose stable for at least 1 week prior to baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Institute for Pulmonary Diseases of Vojvodina
Kamenitz, Serbia, 21204
Actively Recruiting
Research Team
J
Jaehong Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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