drugset / Trial / NCT05629689

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

NCT05629689 ↗

Phase 1 Recruiting 50 enrolled GE Healthcare
Non-randomizedSequentialOpen-labelDiagnostic

Summary

Part A: The purpose of this part is to assess the safety of GEH200520 and GEH200521 (18F) when administered to patients with solid cancer. Subjects will be requested to complete 3 study visits: 1 screening visit, 1 imaging visit (over 24 hours) and 1 follow-up visit (7 days later). The estimated duration of Part A is 21 days. Part B: The purpose of this part of the study is to assess the imaging quality and findings as well as the safety and tolerability of GEH200520 and GEH200521 (18F) when administered to patients with cancer before and after immunotherapy treatment. Subjects will be requested to complete 7 study visits: 1 screening visit, the first imaging visit, followed by 2 immunotherapy immune-checkpoint inhibitor (ICI) treatment visits and 2 additional imaging and 1 follow-up visit. Two late imaging transfer expected post follow up visit. The estimated duration for subject participation in Part B is approximately 64 days.

Timeline

Start
2023-01-27
Primary completion
2029-03-10
Completion
2029-03-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GEH200520 Unknown 1 mg —
Subject GEH200520 Unknown 2 mg —
Subject GEH200520 Unknown 4 mg —
Subject GEH200520 Unknown 8 mg —
Subject GEH200520 Unknown 12 mg —
Subject GEH200520 Unknown 15 mg —
Subject GEH200521 Unknown — —

Indications