Phase 1a1b Study Evaluating Safety and Imaging of GEH200520 and GEH200521 18F Injections in Adults with Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and imaging quality of two investigational drugs, GEH200520 and GEH200521 18F, in patients with solid tumor cancers. The study includes patients who have unresectable or metastatic solid tumors, certain head and neck cancers, or advanced melanoma, and who are eligible for immune-checkpoint inhibitor ICI treatment. This phase 1a1b trial is designed to understand how these drugs behave in the body and how they may change imaging results after ICI treatment. The study is divided into two parts Part A focuses on assessing safety and determining the appropriate dose of GEH200520 combined with a fixed dose of GEH200521 18F through several dose levels. Participants receive the drug injections followed by PETCT scans at various time points, including dynamic and static imaging up to 24 hours post-injection. Part B evaluates the imaging quality, safety, and tolerability of the selected optimal dose in patients undergoing immunotherapy, with multiple imaging visits before and after treatment, and additional follow-up scans. Participants will complete several study visits including screening, imaging sessions, immunotherapy treatment visits, and follow-up assessments over periods ranging from about 21 days in Part A to approximately 64 days in Part B. During the study, researchers will monitor adverse events, vital signs, laboratory tests, electrocardiograms, pharmacokinetics, and immunogenicity. Imaging results will be compared to tumor biopsy findings and standard CT or FDG scans. Safety and tolerability will be closely observed throughout and after drug administration.

A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies