NCT05673538

TT-00973-MS Tablets in Patients With Advanced Solid Tumors

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TT-00973-MS Tablets in Patients With Advanced Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: TransThera Sciences (Nanjing), Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open-label, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TT-00973-MS tablets in patients with solid tumors.

Detailed description

A modified 3+3 design will be used to determine the maximum tolerated dose(MTD) during dose escalation period. Futher expansion period will enroll additional 12\~18 patients at the appropriate dose to futher evaluate the safety and preliminary efficacy of TT-00973-MS.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TT-00973-MS tablets treatment	The dose levels to be tested in the dose escalation cohorts are 2, 5, 10, 17, 25, 32, 40 and 50mg QD. All the subjects will receive TT-00973-MS tablets QD until disease progression or occurrence of intolerant adverse reactions.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2023-01-06
• Last updated: 2023-01-10

Locations

3 sites across 1 country: China