Phase 1 Study of TGI-5 Alone and With Nivolumab for Safety and Antitumor Effects in Adults With Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokineticspharmacodynamics PKPD, and preliminary antitumor effects of a drug called TGI-5 given alone and combined with another drug, Nivolumab, in adults with unresectable locally advanced or metastatic solid tumors. This Phase 1 study includes patients with colorectal cancer, hepatocellular carcinoma, melanoma, non-small cell lung cancer, and other solid tumors who have not responded to or cannot tolerate standard treatments. The study has two parts Phase 1a tests TGI-5 alone starting at a low dose with gradual increases to find the best dose, given every two weeks via intravenous infusion. Phase 1b tests TGI-5 combined with a fixed dose of Nivolumab, also given every two weeks. Each part includes dose escalation to find safe doses and dose expansion to further assess safety and antitumor activity in specific tumor groups. Treatment continues every two weeks unless stopped for progression, side effects, or other reasons. Participants will undergo screening and then receive scheduled infusions of TGI-5 alone or with Nivolumab. They will be monitored for side effects including dose-limiting toxicities during the first 28 days of treatment and have regular assessments of safety, drug levels, and tumor response. The study tracks adverse events from screening until 30 days after the last dose and follows tumor response for about two years. Treatment may be stopped based on disease progression, toxicity, or other factors, with close monitoring throughout.

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