Study to Evaluate Safety and Best Dose of TUB-030 Drug in Adults With Advanced Solid Tumors Including Lung and Head and Neck Cancer

What this Trial Is About

Researchers are evaluating the drug TUB-030 to treat advanced solid tumors in adults, including head and neck cancer and non-small cell lung cancer. This clinical trial aims to determine the safety, tolerability, and best dose of TUB-030 given as a single drug. The study also explores how well the drug works in these cancer types and finds the maximum tolerated dose. Participants will receive TUB-030 through intravenous IV infusion every 3 weeks. The study has two parts a dose escalation phase and a dose optimization phase where patients with non-small cell lung cancer or head and neck cancer are randomly assigned to one of two doses. Each treatment cycle lasts 21 days, with the drug given on day 1. The trial evaluates different doses to find the best balance of safety and potential effect. During the study, participants will visit the clinic every 3 weeks for checkups and tests. Researchers will collect data on adverse events, drug levels in the body, and immune responses from enrollment until 30 days after the last dose. Participants will also complete questionnaires about their symptoms. The main outcome measured is the maximum tolerated dose, while other outcomes include safety, how the drug moves through the body, and its effectiveness. The total study duration depends on treatment cycles and follow-up.

First in Human Study of TUB-030 in Patients With Advanced Solid Tumors