Phase I Study of SC-43 Oral Solution in Subjects With Refractory Solid Tumors
Status:
Withdrawn
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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toxicity, withdrawn consent, disease progression, not receiving medical benefit as considered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.