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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-515218-42-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Cohort 1 - 1 mg dose | Experimental | 1 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
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| Part A Cohort 2 - 2 mg dose | Experimental | 2 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
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| Part A Cohort 3 - 4 mg dose | Experimental | 4 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
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| Part A Cohort 4 - 8 mg dose | Experimental | 8 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
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| Part A Cohort 5 (optional) - 12 or 15 mg dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: The incidence of AEs upon causality to the IMPs. | Part A: 7 days | |
| Part A: The severity of AEs per National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE version 5.0) upon causality to the IMPs. | Part A: 7 days | |
| To evaluate the time-course changes in GEH200521 (18F) Injection uptake after immune-checkpoint inhibitor (ICI) treatment cycles compared to baseline. | Part B: 50 days |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the radiation dosimetry of a fixed dose of GEH200521 (18F) Injection when administered with the different GEH200520 Injection mass doses by cumulated activity in source regions and by entire body. | 7 days | |
| To evaluate the optimal imaging time window for GEH200521 (18F) Injection positron emission tomography (PET) imaging when administered with different GEH200520 Injection mass doses for Part A subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaron Raiter, MD | Contact | +31 6 21288463 | Yaron.Raiter@gehealthcare.com | |
| Shoma Das | Contact | shoma.das@gehealthcare.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaron Raiter, MD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Not yet recruiting | Amsterdam | Netherlands | |||
| UMC Groningen |
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12 or 15 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
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| 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 |
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| 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 |
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| 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. |
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| 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 |
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| 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. |
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| 7 days |
| To determine the appropriate mass dose of GEH200520 Injection for administration with GEH200521 (18F) Injection to achieve an acceptable PET image quality for Part A subjects. | 7 days |
| To characterize the pharmacokinetic (PK) properties (AUC) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | The PK parameter to be assessed: AUC | 7 days |
| To characterize the pharmacokinetic (PK) properties (Cmax) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | The PK parameter to be assessed: Cmax | 7 days |
| To characterize the pharmacokinetic (PK) properties (CL) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | The PK parameter to be assessed: CL | 7 days |
| To characterize the pharmacokinetic (PK) properties (V) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | The PK parameter to be assessed: V | 7 days |
| To characterize the pharmacokinetic (PK) properties (t1/2) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of different GEH200520 Injection mass doses with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | The PK parameter to be assessed: t1/2 | 7 days |
| Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs, for Part A subjects. | Incidence of AEs, SAEs, and Treatment-emergent AEs by system organ class and preferred term | 7 days |
| Changes in physical examination status following administration of GEH200520 and GEH200521 (18F) for Part A subjects | The findings in the physical exam pre and post-administration will be summarized. | Baseline, 24 hours, 7 days post IMP administration |
| Change from baseline in the results of serum biochemistry test results following administration of GEH200520 and GEH200521 (18F) for Part A subjects. | In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized. | Baseline, 24 hours, 7 days post IMP administration |
| Change from baseline in the results of haematology test results following administration of GEH200520 and GEH200521 (18F) for Part A subjects. | Change from baseline in the results of haematology test results following administration of GEH200520 and GEH200521 (18F) for Part A subjects. | Baseline, 24 hours, 7 days post IMP administration |
| Changes in heart rate as beats per minute following administration of GEH200520 and GEH200521 (18F) for Part A subjects | The occurrence of post-administration heart rate values outside the normal limits will be summarized. | Baseline, 2 hours, 24 hours, 7 days post IMP administration |
| Changes in blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F) for Part A subjects | The occurrence of post-administration blood pressure values outside the normal limits will be summarized. | Baseline, 2 hours, 24 hours, 7 days post IMP administration |
| Changes in temperature as degree C following administration of GEH200520 and GEH200521 (18F) for Part A subjects | The occurrence of post-administration body temperature values outside the normal limits will be summarized. | Baseline, 2 hours, 24 hours, 7 days post IMP administration |
| Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F) for Part A subjects | Descriptive statistics will be used to describe the observed values and change from baseline. | Baseline, 2 hours, 24 hours, 7 days post IMP administration |
| To assess immunogenicity, via the incidence of treatment-induced anti-drug antibodies responses, after a single injection of the different GEH200520 Injection mass doses administered with a fixed dose of GEH200521 (18F) Injection for Part A subjects. | 7 days |
| Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs | 50 days |
| To assess the biodistribution and tumour uptake of GEH200521 (18F) Injection with the optimal GEH200520 Injection dose determined in Part A based on quantitative measurements of GEH200521 (18F) in regions of interest for Part B subjects. | 50 days |
| To assess the relationship between tumour GEH200521 (18F) Injection uptake (SUV value) and immune cell CD8+ expression score from a biopsy sample/resected lesion when available based on IHC results for Part B subjects. | 50 days |
| To compare changes in tumour GEH200521 (18F) Injection uptake with changes in computed tomography (CT) image assessment, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 for Part B subjects when available . | 50 days |
| To compare changes in tumour GEH200521 (18F) Injection uptake with changes in computed tomography (CT) image assessment, according to [18F]-fluorodeoxyglucose (FDG) scans, when available for Part B subjects. | 50 days |
| Changes in physical examination status following administration of GEH200520 and GEH200521 (18F) for Part B subjects | The occurrence of post-administration physical exam status values outside the normal limits will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Change from baseline in the results of serum biochemistry test results following administration of GEH200520 and GEH200521 (18F) for Part B subjects. | In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Change from baseline in the results of haematology test results following administration of GEH200520 and GEH200521 (18F) for Part B subjects. | In this context, baseline is defined as the pre-treatment assessment at the screening visit. The occurrence of post injection values outside of normal limits and changes from baseline will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Changes in heart rate as beats per minute following administration of GEH200520 and GEH200521 (18F) for Part B subjects | The occurrence of post-administration heart rate values outside the normal limits will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Changes in blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F) for Part B subjects | The occurrence of post-administration blood pressure values outside the normal limits will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Changes in temperature as degree C following administration of GEH200520 and GEH200521 (18F) for Part B subjects | The occurrence of post-administration body temperature values outside the normal limits will be summarized. | Baseline, Day 15, Day 36, Day 50 |
| Change from baseline in the results of 12-lead electrocardiograms (ECGs) following administration of GEH200520 and GEH200521 (18F) for Part B subjects | Descriptive statistics will be used to describe the observed values and change from baseline. | Baseline, Day 15, Day 36, Day 50 |
| To characterize the PK properties (AUC) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | The PK parameter to be assessed: AUC | 50 days |
| To characterize the PK properties (Cmax) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | The PK parameter to be assessed: Cmax | 50 days |
| To characterize the PK properties (CL) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | The PK parameter to be assessed: CL | 50 days |
| To characterize the PK properties (V) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | The PK parameter to be assessed: V | 50 days |
| To characterize the PK properties (t1/2) of total protein (GEH200520 and [18F]GEH200521 combined) following administration of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | The PK parameter to be assessed: t1/2 | 50 days |
| To compare immunogenicity, via the incidence of treatment-induced anti-drug antibodies responses, after multiple administrations of GEH200520 Injection with GEH200521 (18F) Injection for Part B subjects. | 50 days |
| Recruiting |
| Groningen |
| Netherlands |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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