Phase 1 Study of TGI-6 as a Single Treatment for Adults With Locally Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are conducting a Phase 1 study to assess the safety, tolerability, pharmacokineticspharmacodynamics PKPD, and preliminary anti-tumor effects of TGI-6 given alone to adults with unresectable locally advanced or metastatic colorectal cancer CRC or other B7-H6-positive solid tumors such as triple-negative breast cancer, liver cancer, head and neck cancers, small cell lung cancer, ovarian cancer, gastric cancer, pancreatic cancer, and melanoma. The study aims to understand how the drug behaves in the body and its potential to control tumor growth in these advanced cancers. The study includes two parts Phase 1a focuses on dose escalation to find a safe and tolerable dose of TGI-6, while Phase 1b involves dose expansion to further evaluate safety and activity at the selected dose. TGI-6 is administered intravenously according to the dosing schedule specified for each part and cohort. Participants go through a screening period of up to 28 days before starting treatment, continue treatment until discontinuation, and then enter a follow-up period for safety and survival monitoring. Participants will have regular assessments including evaluations of adverse events, tumor response measured by RECIST criteria, pharmacokinetic sampling for TGI-6 levels, and antibody testing against TGI-6. Safety monitoring includes tracking dose-limiting toxicities within the first 21 days and adverse events up to 30 days after the last dose. The study also follows participants for up to approximately three years to assess tumor response rates, duration of response, disease control, progression-free survival, and overall survival. Women of childbearing potential and their partners must use effective contraception during and for six months after the study treatment.

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