A Phase 1 Study of TGI-5 as Monotherapy and in Combination With Nivolumab in Subjects With Locally Advanced/Metastatic Solid Tumors

This is a Phase 1, multicenter, open-label, two-parts, FIH study to evaluate the tolerability, safety, PK/PD, and preliminary antitumor activity of TGI-5 as monotherapy and in combination with Nivolumab in subjects with unresectable locally advanced/metastatic solid tumors. The study consists of two parts: TGI-5 monotherapy (Phase 1a: including a dose escalation part and a dose expansion part), TGI-5 in combination with a fixed dose of Nivolumab (Phase 1b: including a dose escalation part and a dose expansion part).

NCT Number	NCT07376707
Lead Sponsor	Hefei TG ImmunoPharma Co., Ltd. Collaborators: Tigermed Consulting Co., Ltd
Conditions	CRC (Colorectal Cancer), Melanoma (Skin Cancer), HCC - Hepatocellular Carcinoma, NSCLC (Non-small Cell Lung Cancer)
Enrollment	194 participants
Start Date	2025-06-12
Primary Completion	2027-10-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-29