NCT05970016

A Phase I/II Clinical Study in Patients with Advanced Solid Tumor.

A Phase I/II Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TCC1727 Tablets in Patients with Advanced Solid Tumor.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part, phase I/II, open-label, multicenter study designed to evaluate the safety, PK, PD and preliminary efficacy of TCC1727 tablets administered orally QD.

Detailed description

The study will be divided into two stages: the first stage is a phase I dose finding study in patients with advanced solid tumors; the second stage is a phase II cohort expansion study.

Conditions

• Patients with Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	TCC1727 tablet（1）	TCC1727 tablet will be administered orally once a day (QD) every morning for 3 days followed by discontinuation for 4 days, and 21 days/cycle on an empty stomach.
DRUG	TCC1727 tablet（2）	Drug: TCC1727 tablet TCC1727 tablet will be administered orally twice a day (BID) every morning , and 21 days/cycle on an empty stomach.

Timeline

• Start date: 2023-08-07
• Primary completion: 2025-07-30
• Completion: 2025-12-30
• First posted: 2023-08-01
• Last updated: 2025-03-21

Locations

1 site across 1 country: China