NCT03020823

To Evaluate the Efficacy and Safety of SCB01A in Subjects With r/m Squamous Cell Head and Neck Cancer

An Open-Label, Phase II Study to Evaluate the Efficacy and Safety of SCB01A in Subjects With Recurrent or Metastatic Squamous Cell Head and Neck Cancer Who Have Failed Platinum-Based Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: SynCore Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.

Detailed description

From pre-clinical pharmacology and phase I clinical study SCB01A has demonstrated promising anticancer action with a vascular disrupting activity that has the potential for treatment of various malignancies, particularly for patients with drug resistance. The drug has been studied in human subjects in a dose escalation phase I study and has shown to be safe for up to 2 cycles of 24 mg/m2 (each cycle consisting of one intravenous \[i.v.\] administration of SCB01A via a central line every 3 weeks). In the phase I study, partial response (PR) (shrinkage of tumor size to 50%) was observed in cycle 9 (3 mg/m2) of one subject with right buccal squamous cell carcinoma and 19/33 (58%) subjects had stable disease (SD) for more than 2 cycles. Pre clinical study of SCB01A showed that the concentrations at which tubulin inhibition occurred were around 80 nM for 24-hour exposure or 200 nM for 6-hour exposure. However, pharmacokinetic (PK) results of phase I study showed that the average elimination half-life (t1/2) of a 3-hours i.v. infusion of SCB01A is approximately 2.5 hours and almost no SCB01A can be detected after 10 hours, indicating most subjects were treated in short API exposure time and may have been insufficient to achieve efficacy. Therefore, to extend the exposure duration above effective concentration in blood may increase the treatment efficacy. The aim of this study is to evaluate the efficacy and safety of i.v. infusion for 24-hour of SCB01A in subjects with squamous cell carcinoma of head and neck who have failed previous platinum based therapies.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	SCB01A	intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.

Timeline

• Start date: 2017-04-30
• Primary completion: 2018-11-20
• Completion: 2018-11-20
• First posted: 2017-01-13
• Last updated: 2023-06-05
• Results posted: 2023-06-02

Locations

4 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study