NCT04640480CompletedPhase 1
Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
A Phase I, Open-Label, Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenously Infused SNB-101(as SN-38) in Patients With Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
SNB-101 is a novel nano-particle formulation of SN-38, the active metabolite of irinotecan(CPT-11). Study SNB101P01 is a multicenter, open-label, dose escalation, phase 1 study of SNB 101 with its active ingredient SN-38, in participants with advanced solid tumors. Dose escalation will occur using a modified accelerated titration design (ATD). All participants will receive SNB 101 in different cohorts. SNB 101 will be administered intravenously to participants on day 1 and day 15 of each 28 day treatment cycle until progressive disease, unacceptable toxicity, death, or withdrawal of consent, whichever occurs first. A Safety Review Committee will determine dose escalation, de-escalation, and modification and the MTD/RP2D based on DLTs and other safety information.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 22 Oct 2020
- Start date
- 21 Oct 2020
- Primary completion date
- 5 Jan 2026
- Lead sponsor
- SN BioScience
- Diseases
- Head and neck cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Gastric and esophageal cancer, Ovarian cancer
- NCT number
- NCT04640480
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 21
- From 21 Oct 2020 to the primary completion date, 5 Jan 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with unintentional weight loss \>10% within 3 months prior to screening.
- Patients who may require attenuated vaccine during the study.
- Patients who are taking any medication that in the judgement of the investigator could have an effect on the action of SNB-101.
Other illness
- Patients known or suspected intolerance or hypersensitivity to main ingredient or any of the excipients of SNB-101.
- Patients with chronic inflammatory bowel disease.
Lab values
- Patients with a QT interval with Fridericia's correction outside of normal.
Other
- Patients homozygous for UGT1A1\*28 or UGT1A1\*6 alleles.
- Patients who are on dialysis.
- Patients who are positive for HIVs.
- Patients with intestinal palsy or bowel obstruction.
- Patients who may require administration of neuromuscular blockers, peripheral muscle relaxants, etc. during the study.
- Patients who may require lapatinib during the study.
- Patients unable to participate in the study as judged by the investigator.
Who the study is looking for
- Patients with a histologically or cytologically confirmed, locally advanced or metastatic disease, has progressed after systemic standard of care treatment for advanced disease and is not suitable for complete surgical resection.
- Patients with measurable or evaluable disease consistent with Response Evaluation Criteria in Solid Tumors version 1.1.
- Patients ambulatory with an Eastern Cooperative Oncology Group performance score of 0 or 1.
- Patients with adequate hematological, renal, and liver function(CTCAE V5.0 grade 1 or lower).
- Patients with the life expectancy of 3 months or longer.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHA Medical Center Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Severance Hospital of the Yonsei University Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.