NCT04958434

Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

A Phase 1, First in Human, Open-label, Dose Escalation and Dose Expansion Study of TST005 in Patients With Locally Advanced or Metastatic Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Suzhou Transcenta Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label Phase 1, first-in-human (FIH) study of TST005, a bi-specific antibody consisting of a PD-L1 monoclonal antibody (mAb) and a transforming growth factor beta (TGF-β) trap in subjects with locally advanced or metastatic cancers

Detailed description

The study has 2 parts. Part A is a dose escalation portion where the patients will be doses every three weeks following an accelerated 3+3 design. This portion will enroll approximately 25 patients with locally advanced or metastatic cancers. Part B is an expansion portion where approximately 30 additional patients will be dosed at the recommended dose level every 3 weeks. This part will include patients with locally advanced or metastatic HPV related malignancies. The trial will last approximately 2 years, with assessments including safety labs, ECGs, PKs and PDs and CT/MRI tumor assessments, based on the Q3W dosing schedule.

Conditions

• Locally Advanced or Metastatic Cancers
• Metastatic Human Papillomavirus-Related Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	TST005	TST005 is a bifunctional human immunoglobulin G1 (IgG1) monoclonal

Timeline

• Start date: 2021-06-11
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-07-12
• Last updated: 2023-10-23

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study