NCT06374173

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Hefei TG ImmunoPharma Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	TGI-6 Injection	TGI-6 will be administered intravenously at a dose and schedule as specified for the respective study part and cohort.

Timeline

• Start date: 2024-01-03
• Primary completion: 2027-09-01
• Completion: 2027-12-01
• First posted: 2024-04-18
• Last updated: 2024-04-18

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study