Phase 12A Study of GV20-0251 Alone and With Pembrolizumab for Advanced or Resistant Solid Tumors

What this Trial Is About

Researchers are studying GV20-0251, a biological treatment, alone and combined with pembrolizumab for adults with advanced solid tumors that have not responded to standard treatments. This open-label Phase 12A trial aims to find safe doses and understand the treatments effects on various tumor types, including endometrial carcinoma, head and neck carcinoma, melanoma, lung cancer, and certain colon or rectal cancers. The study has four parts Part A uses a dose escalation method to find the best dose of GV20-0251 alone. Part B expands testing of this dose in different tumor groups. Part C tests GV20-0251 combined with pembrolizumab at increasing doses. Part D expands the combination treatment in more tumor groups. Treatments are given by intravenous infusions every three weeks, with dosing adjusted based on safety and response. Participants will undergo tumor biopsies before and during treatment when possible. Researchers will monitor safety, side effects, and how the drugs behave in the body, along with tumor responses using standard criteria over up to 24 months. The main outcomes include tumor response rates and adverse events. The study involves multiple visits for infusions, assessments, lab tests, and biopsies, with careful monitoring throughout the trial period.

A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies