OncRef

Clinical Trial: NCT04640480

Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:SN BioScience
Information Provided By:SN BioScience
Last Update Posted:2026-01-27

Study Overview

Brief Summary

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.

Official Title

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

Conditions

Colorectal Cancer, Breast Cancer, Pancreas Cancer, Ovarian Cancer, Small-cell Lung Cancer, Gastric Cancer, Head and Neck Cancer

Intervention / Treatment

  • Drug: SNB-101

Other Study ID Numbers

  • SNB-101-101

Start Date (Actual)

2020-10-21

Primary Completion Date (Actual)

2026-01-05

Study Completion Date (Actual)

2026-01-05

Enrollment (Actual)

21

Study Type

Interventional

Phase

Phase 1