NCT05088070

Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors

Phase I Clinical Study of SPH3348 Tablets, a C-Met Inhibitor, in Patients with Advanced Solid Tumors with C-Met Abnormalities

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 clinical trial of SPH3348 tablets, a c-Met inhibitor, in patients with advanced solid tumors with c-Met abnormalities. A modified 3 + 3 design was adopted in patients with advanced solid tumors with c-Met abnormalities, with a total of 6 dose groups, in which accelerated dose escalation was adopted for the lowest dose group, and 3 + 3 dose escalation was adopted from the second dose group. The primary objective was to evaluate the safety and tolerability of SPH3348 tablets in patients with advanced solid tumors with c-Met abnormalities.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	SPH 3348	2 tablets of 8mg SPH3348 will be orally administered once a day with empty stomach
DRUG	SPH 3348	1 tablet of 40mg SPH3348 will be orally administered once a day with empty stomach
DRUG	SPH 3348	2 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
DRUG	SPH 3348	4 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
DRUG	SPH 3348	6 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach
DRUG	SPH 3348	8 tablets of 40mg SPH3348 will be orally administered once a day with empty stomach

Timeline

• Start date: 2020-07-02
• Primary completion: 2023-07-30
• Completion: 2023-07-30
• First posted: 2021-10-21
• Last updated: 2024-08-30

Locations

1 site across 1 country: China