NCT04866641

Safety and Tolerability Study for T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of T-1201 Injection 100 mg Kit in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Taivex Therapeutics Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201 injection in subjects with advanced solid tumors refractory to standard therapy, or for whom no standard therapy is available. The main questions it aims to answer are: * The Maximum tolerated dose (MTD) of T-1201 on different dosing schedules. * The Recommended Phase 2 dose (RP2D) of T-1201 on different dosing schedules. Researchers will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of T-1201. Participants will: Received T-1201 either once every 4 (Part A)/2 (Part B)/3 (Part C) weeks, depend on they participate in which parts of study. Visit the clinic once every 2/3 weeks for checkups and tests

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	T-1201 Injection 100 mg Kit	T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.

Timeline

• Start date: 2021-06-24
• Primary completion: 2026-06-30
• Completion: 2027-07-31
• First posted: 2021-04-30
• Last updated: 2025-05-30

Locations

2 sites across 1 country: Taiwan

Regulatory

• FDA-regulated drug study