Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GEH200520 Injection and GEH200521 (18F) Injection, GEH200520 and GEH200521
GEH200520/GEH200521 · 2 trials · 3 indications
Incidence of all grading of TEAEs per National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 based on the causality to the IMPs.
| Arm | Type | Description |
|---|---|---|
| A non-radiolabeled GEH200520 - 1 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 2 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 4 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 6 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 8 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 10 mg | EXPERIMENTAL | - |
| A non-radiolabeled GEH200520 - 12 mg or 15 mg | EXPERIMENTAL | - |
| 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 and GEH200521 (18F) Injection | DRUG | Administration of GEH200520 Injection followed by GEH200521 (18F) Injection |
| Static - PET/CT scan | DIAGNOSTIC_TEST | Repeat whole body static scan starting 3 minutes after injection followed by a single whole body static scan at 2 to 3 hours after injection and 4 to 5 hours after injection |
| 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 |
Inclusion Criteria: * The subject is able and willing to comply with all study procedures as described in the protocol, and has read, signed, and dated an informed consent form prior to any study procedures being performed. * The subject is male or female ≥18 years of age. * The subject has a body ...