Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Small-cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNB-101 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- SNB-101 5/8mg/m2 Q2W IV
- interventionNames
- Drug: SNB-101
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- SNB-101 10/16mg/m2 Q2W IV
- interventionNames
- Drug: SNB-101
- type
- EXPERIMENTAL
- label
- Cohort 3
- description
- SNB-101 20/32mg/m2 Q2W IV
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Patients homozygous for UGT1A1\*28 or UGT1A1\*6 alleles. * Patients known or suspected intolerance or hypersensitivity to main ingredient or any of the excipients of SNB-101. * Patients with unintentional weight loss \>10% within 3 months prior to screening. * Patients who are on dialysis. * Patients who are positive for HIVs. * Patients with a QT interval with Fridericia's correction outside of normal. * Patients with intestinal palsy or bowel obstruction. * Patients with chronic inflammatory bowel disease. * Patients who may require administration of neuromuscular blockers, peripheral muscle relaxants, etc. during the study. * Patients who may require lapatinib during the study. * 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. * Patients unable to participate in the study as judged by the investigator.
References
Publications (0)
Data not yet available