Phase I Study Evaluating Safety and Recommended Dose of KGX101 Alone and With Envafolimab in Advanced or Metastatic Solid Tumor Patients

What this Trial Is About

This trial investigates advanced or metastatic solid tumors in patients who have not responded to standard treatments. It is a phase I, open-label, multi-center study designed to explore the safety and tolerability of the drug KGX101 alone and in combination with Envafolimab in Chinese patients. The study also aims to determine the recommended dose for phase 2 of KGX101 both as a monotherapy and combined with Envafolimab. Participants will receive KGX101 either alone or alongside Envafolimab every three weeks. The study involves dose escalation and expansion phases with different dose levels of KGX101 monotherapy and combination therapy. KGX101 is given as an injection, and Envafolimab is a subcutaneous injection. The dosing schedule includes about 6 to 8 visits in the first month, followed by visits approximately every three weeks thereafter. During the study, participants will attend clinic visits for various checkups and tests, including monitoring for adverse events and laboratory abnormalities. Researchers will assess tolerability, dose-limiting toxicities, drug pharmacokinetics, immune response, and tumor responses using criteria such as RECIST 1.1. Follow-ups will continue every 90 days after treatment to evaluate progression-free and overall survival. The study duration extends from the first dose until up to 90 days after the last dose, including safety monitoring.

A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients