MedTrace Logo

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

NCT05088070 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zishu Wang · The First Affliated Hospital of Bengbu Medical College

  • Huan Zhou · The First Affliated Hospital of Bengbu Medical College

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05088070 on ClinicalTrials.gov