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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SN BioScience

Criteria

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.