NCT02759640

A Phase I Trial of HS-10241 in Solid Tumors

First-in-Human, Dose-Escalation Trial of C-Met Kinase Inhibitor HS-10241 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Atridia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1, open-label, dose-escalation trial of HS-10241 as monotherapy in subjects with solid tumors. HS-10241 will be administered orally once daily.

Detailed description

Recently, c-Met has become an important target of intensive research in search of specific inhibitors as potential new therapies for cancers driven by c-Met activation. HS-10241 is a potent and selective small molecule c-Met kinase inhibitor for both enzyme and c-Met phosphorylation in the cell. Consistent with its potent enzyme and cell activity, HS-10241 was found to inhibit cell growth in vitro against tumors with c-Met gene amplification or c-Met overexpression. On the basis of these findings, the current trial will be conducted in participants with advanced solid tumors for whom standard treatment is not currently available. This study consists of 2 phases. In the dose-escalation phase, up to 5 dose levels of HS-10241 (100 mg/day, 200 mg/day, 340 mg/day, 500 mg/day, and 700 mg/day) will be investigated with a sequential "3+3" design (3 or 6 participants in every dose level). Participants will have a single-dose pharmacokinetic (PK) run-in period (7 days). Following the first dose, participants will enter a 1 week treatment-free period to evaluate safety and single-dose PK. If no dose-limiting toxicities (DLTs) are observed during the 1-week period, HS-10241 administration will resume at the same dose level. In the expansion phase, up to 12 additional participants will be enrolled at the MTD. Anti-tumor effects will be assessed every 2 cycles (4 weeks=1 cycle) by using RECIST version 1.1 criteria.

Conditions

• Neoplasm
• Solid Tumors

Interventions

Type	Name	Description
DRUG	HS-10241	HS-10241 is administered orally starting at 100 mg/day.

Timeline

• Start date: 2016-09-01
• Primary completion: 2018-03-01
• Completion: 2018-05-01
• First posted: 2016-05-03
• Last updated: 2022-07-20

Locations

2 sites across 1 country: Australia