NCT05434299

A Study of TFX05-01 in Patients With Advanced Solid Tumors

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TFX05-01 in Participants With Advanced Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Zhejiang Yangli Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, non-randomized, multicenter, Phase Ⅰ/Ⅱa study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors.

Detailed description

The study to evaluate the safety, tolerability, pharmacokinetics and efficacy of TFX05-01 in patients with advanced solid tumors, which was divided into dose exploration part (Phase Ⅰ) and indication exploration part (Phase Ⅱa). Each Phase of the study consisted of a screening period (21 days before initial dosing), a treatment period (from the first trial to the onset of an endpoint event), and a follow-up period.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	TFX05-01	TFX05-01 for intravenous

Timeline

• Start date: 2022-06-05
• Primary completion: 2024-12-01
• Completion: 2025-12-01
• First posted: 2022-06-28
• Last updated: 2023-03-16

Locations

4 sites across 1 country: China