Phase I Dose-Escalation Study of SCB01A, a Microtubule Inhibitor with Vascular Disrupting Activity, in Patients with Advanced Solid Tumors
Journal
Oncologist
Journal Volume
26
Journal Issue
4
Pages
e567-e579
Date Issued
2021
Author(s)
Shiah H.-S.
Chiang N.-J.
Yen C.-J.
Tsai H.-J.
Wu S.-Y.
Su W.-C.
Chang K.-Y.
Wang C.-C.
Chang J.-Y.
Chen L.-T.
Abstract
LESSONS LEARNED: SCB01A is a novel microtubule inhibitor with vascular disrupting activity. This first-in-human study demonstrated SCB01A safety, pharmacokinetics, and preliminary antitumor activity. SCB01A is safe and well tolerated in patients with advanced solid malignancies with manageable neurotoxicity. BACKGROUND: SCB01A, a novel microtubule inhibitor, has vascular disrupting activity. METHODS: to the maximum tolerated dose (MTD) based on dose-limiting toxicity (DLT). SCB01A-induced cellular neurotoxicity was evaluated in dorsal root ganglion cells. The primary endpoint was MTD. Safety, pharmacokinetics (PK), and tumor response were secondary endpoints. RESULTS: , and average half-life was ~2.5 hours. The area under the curve-dose response relationship was linear. Nineteen subjects were stable after two cycles. The longest treatment lasted 24 cycles. SCB01A-induced neurotoxicity was reversible in vitro. CONCLUSION: every 21 days; it is safe and tolerable in patients with solid tumors.
SDGs
Publisher
John Wiley and Sons Inc
Type
journal article