Phase I Study of SC-43 Oral Solution in Subjects With Refractory Solid Tumors

Refractory Solid Tumor Clinical Trial

Official title: Phase I Open-Label Dose-Escalating Study to Determine the Safety, Tolerability, Maximum Tolerated Dose, and Pharmacokinetics of SC-43 Oral Solution in Subjects With Refractory Solid Tumors

Status Withdrawn

Clinical Trial Summary

This phase I study will be conducted in an open-label, conventional 3+3 dose escalation design manner (for the first 28 days of dosing) followed by an extension period for subjects responsive to the study drug to continue dosing up to 52 weeks. This study is intended to assess the safety and efficacy of the investigational product (IP), SC-43 Oral Solution, in subjects with refractory solid tumors. Subjects who have diseases progressing unresponsive to the previous treatments or who have no standard treatments for their current diseases will be enrolled in this study once the eligibility is confirmed.

During the first 28 days, the study will be done in the conventional 3+3 design to determine the maximum tolerated dose (MTD) of SC-43 Oral Solution. The dose will be increased in a step-wise fashion from the initial dose of 100 mg/day to the dose of 200, 400, 600, 900, and 1200 mg/day. The pharmacokinetics (PK) of SC-43 will also be measured in this period.

The dose of SC-43 Oral Solution will be escalated to the subsequent cohorts when there is no dose-limiting toxicity (DLT) in 3 subjects or only one DLT in 6 subjects of the previous cohort, and it is recommended by Data and Safety Monitoring Board (DSMB). The safety results will be reviewed by DSMB after the last subject in the each cohort has finished the Visit 6 (Day 29), and DSMB will determine if it is safe to proceed to the next dose cohort.

Subjects who have finished the 28-day dose escalation period and with complete response (CR), partial response (PR), or stable disease (SD) will be eligible to enter the extension period and continue SC-43 Oral Solution therapy up to 52 weeks or until occurrence of unacceptable toxicity, withdrawn consent, disease progression, not receiving medical benefit as considered by investigators, loss of follow-up, or death, whichever comes first. For ethical and safety concerns, the dosage used in this extension period can be adjusted and different from the original dosage assignment. The actual dose of SC-43 Oral Solution, which must be confirmed safe, administered during this extension period will be at the investigator's discretion.

Clinical Trial Description

SC-43, has been shown to enhance the activity of Src homology region 2 domain-containing phosphatase-1 (SHP-1), leading suppression of STAT3 phosphorylation and tumor growth inhibition. SC-43 enhances SHP-1 activity by impairing the association between the N-SH2 domain and the PTP domain of SHP-1, triggering a conformational change of SHP-1 and relieving its autoinhibition. SC-43 treatment leads to cancer cell death in multiple cancer cell lines. SC-43 also exhibits anti-cancer activity in a variety of nonclinical xenograft tumor models. ;

Related Conditions & MeSH terms

• Neoplasms
• Refractory Solid Tumor

• NCT number: NCT03443622
• Study type: Interventional
• Source: SupremeCure Pharma Inc.
• Status: Withdrawn
• Phase: Phase 1
• Start date: May 2021
• Completion date: June 2023