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

Trial ID: NCT04640480

Interventional - Phase 1 - Completed

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

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

Interventions

• SNB-101

Eligibility

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.

Sponsor

SN BioScience

Source: ClinicalTrials.gov

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