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GEH200520/GEH200521 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Part A Cohort 1 - 1 mg dose | EXPERIMENTAL | 1 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 2 - 2 mg dose | EXPERIMENTAL | 2 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 3 - 4 mg dose | EXPERIMENTAL | 4 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 4 - 8 mg dose | EXPERIMENTAL | 8 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 5 (optional) - 12 or 15 mg dose | EXPERIMENTAL | 12 or 15 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 6 - Optimal dose | EXPERIMENTAL | Selected (optimal) mass dose as determined from results of Cohorts 1 through 5 of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part B | EXPERIMENTAL | Selected (optimal) dose of GEH200520 Injection from Part A with fixed dose of GEH200521 (18F) Injection administered together in 3 sequential repeat imaging visits |
| Name | Type | Description |
|---|---|---|
| GEH200520 Injection / GEH200521 (18F) Injection - Part A | DRUG | Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush |
| Dynamic and Static - PET/CT scan | DIAGNOSTIC_TEST | Dynamic whole-body PET/CT scan starting at the time of injection (sequential scans over 90 minutes anticipated) followed by static whole-body scans starting at 150 minutes, 270 minutes, and (optional) 24 hours after injection. |
| GEH200520 Injection / GEH200521 (18F) Injection - Part B | DRUG | Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush |
| Static - PET/CT scan | DIAGNOSTIC_TEST | Whole-body PET/CT scan (up to 30 min). Exact timing will be determined from Part A. An optional dynamic scan may be acquired in addition to the required whole-body PET/CT scan at each imaging visit. |
Inclusion Criteria: * The subject is able and willing to comply with all study procedures as described in the protocol, including the imaging day pre-visit requirements, and has read, signed, and dated an informed consent form prior to any study procedures being performed. * The subject is male or ...
GEH200520/GEH200521 is an investigational small molecule imaging agent being developed for PET scans in patients with malignant solid tumors. It is being studied in a Phase 1 trial to evaluate its safety and tolerability when used for PET imaging in patients with solid tumor malignancies.
GEH200520/GEH200521 is being studied for use in PET scans in patients with malignant solid tumors. The Phase 1 trial is designed to evaluate the safety and tolerability of the agent when used for PET imaging in this patient population.
GEH200520/GEH200521 is being developed by GE HealthCare Technologies Inc., which trades under the ticker GEHC. The company is running a Phase 1 study of the imaging agent in patients with solid tumor malignancies.
GEH200520/GEH200521 is in Phase 1 clinical development. It is investigational and is being evaluated in a single recruiting trial, with no completed trials reported to date.
GEH200520/GEH200521 is being studied in the Phase 1 trial NCT05629689, titled a study to evaluate GEH200520/GEH200521 (18F) safety and tolerability when used for PET scans in patients with solid tumour malignancies. The trial is recruiting in the Netherlands and plans to enroll 50 participants.