Locally Advanced (Unresectable) or Metastatic Solid Tumors Clinical Trial
Official title:
A Multicenter, Open-label, Phase 1 Dose Escalation and Expansion Study of TXN10128, an Inhibitor of ENPP1 in Subjects With Locally Advanced (Unresectable) or Metastatic Solid Tumors
This is a phase I clinical trial to primarily evaluate the safety, tolerability, and addtionally assess pharmacokinetics, pharmacodynamics, and antitumor activity of investigational product, TXN10128. The target subjects will be consisted of patients with locally advanced (unresectable) or metastatic soild tumors.
This study is a multicenter, open-label, phase 1 study of TXN10128, an inhibitor of ENPP1 (ectonucleotide pyrophosphatase/phosphodiesterase 1). Patients with locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment will be enrolled. The primary objective is evaluating the safety and tolerability of TXN10128 to determine the MTD. The secondary objective is characterizing the PK profile and evaluating preliminary antitumor activity of TXN10128. This study consists of the dose-escalation and dose-expansion part. In dose-escalation part, maximally 36 subjects can be enrolled across planned 6 dose levels. Bayesian optimal interval (BOIN) design will be employed to find the MTD. The target DLT rate for determining the MTD is 30% for this study. TXN10128 will be administered orally once daily for 21 days as a treatment cycle. ;