drugset / Trial / NCT05088070

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

NCT05088070 ↗

Phase 1 Completed 40 enrolled Shanghai Pharmaceuticals Holding Co., Ltd
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2020-07-02
Primary completion
2023-07-30
Completion
2023-07-30

Drugs

EvaluationDrugModalityDoseRoute
Subject SPH3348 Unknown 16 mg Oral
Subject SPH3348 Unknown 40 mg Oral
Subject SPH3348 Unknown 80 mg Oral
Subject SPH3348 Unknown 160 mg Oral
Subject SPH3348 Unknown 240 mg Oral
Subject SPH3348 Unknown 320 mg Oral

Indications