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A Phase 1 Study to Evaluate TGI-6 in Subjects With Locally Advanced/Metastatic Solid Tumors

Advanced or Metastatic Solid Tumors Clinical Trial

Official title:
A Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics/ Pharmacodynamics, and Antitumor Activity of TGI-6 as Monotherapy in Subjects With Locally Advanced/Metastatic Solid Tumors

Clinical Trial Summary

A Phase 1 Study to Evaluate TGI-6 in Subjects with Locally Advanced/Metastatic Solid Tumors

Clinical Trial Description

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary anti-tumor activity of TGI-6 as monotherapy in subjects with unresectable locally advanced/metastatic CRC, or subjects with confirmed B7-H6-positive locally advanced/metastatic solid tumors. The study consists of two parts: a dose escalation part (Phase 1a) and a dose expansion part (Phase 1b). For each subject in the two parts, the study will include a screening period (up to 28 days), a treatment period (until treatment discontinuation), and a follow-up period including safety and survival follow-up. ;

Study Design

Related Conditions & MeSH terms

  • Advanced or Metastatic Solid Tumors
  • Neoplasms
Clinical Trial Details
NCT number NCT06374173
Study type Interventional
Source Hefei TG ImmunoPharma Co., Ltd.
Contact Xiaohu Zheng, Doctorate
Phone +86 0551-62861151
Email xiaohu.zheng@tgimmunopharma.com
Status Recruiting
Phase Phase 1
Start date January 3, 2024
Completion date December 2027
View Details
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