Malignant Solid TumorPhase 1NCT05629689
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
A Phase 1 study testing GEH200520 Injection / GEH200521 (18F) Injection - Part A, Dynamic and Static - PET/CT scan and GEH200520 Injection / GEH200521 (18F) Injection - Part B in people with Malignant Solid Tumor and Oncology, run by GE Healthcare at 2 sites in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Solid Tumor, Oncology
- What is being tested?
- GEH200520 Injection / GEH200521 (18F) Injection - Part A, Dynamic and Static - PET/CT scan and GEH200520 Injection / GEH200521 (18F) Injection - Part B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Jan 2023to 4 Aug 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 female, ≥18 years of age.
- Subject has a life expectancy ≥12 weeks.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subject has an unresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma, or an unresectable stage III-IV melanoma.
- Subject is eligible for ICI treatment per Investigator judgement.
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- Subject has at least 1 measurable tumour lesion documented on CT/magnetic resonance imaging (MRI) RECIST v1.1 during the last 12 months.
- Subject has a tumour lesion(s) of which a biopsy can safely be obtained according to standard clinical care procedures.
- Subject is male or female that agrees to adhere to the protocol contraception methods.
Who cannot join
- Subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure.
- Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.
- Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
- Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
- Subject has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
- Subject has B or T cell lymphoma.
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- Subject has brain or bone-marrow metastasis that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
- Subject has signs or symptoms of systemic infection within 2 weeks prior to imaging day.
- Subject has history of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanised antibodies or fusion proteins or known allergy to the study IMP ingredients and/or the proposed ICI therapy.
- Subject has any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the ICI treatment, or that may affect the interpretation of the results or render the subject at high risk from complications.
- Subject has laboratory values out of range per protocol.
- Subject has any safety laboratory test results (blood chemistry, haematology, and urinalysis) that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
- Subject has had any major surgery within 4 weeks prior to enrollment.
- Subject has been enrolled in another interventional clinical study within the 30 days before screening for this study, except for the study site IIS.
- Subject is pregnant or planning to become pregnant or is breastfeeding.
- Subject has a history of alcohol or drug abuse within the last year.
- Subject has had treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to dosing with the IMP.
- Subject has had treatment with systemic immunosuppressive medications within 2 weeks prior to dosing with the IMP.
- Subject has received acute, low-dose, systemic immunosuppressant medications that, in the opinion of the Investigator, could compromise protocol objectives.
- Subject has used systemic corticosteroids to treat inflammatory or autoimmune symptoms.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1a/1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients With Solid Tumour Malignancies to Evaluate GEH200520 Injection / GEH200521 (18F) Injection Safety and Tolerability, PET Imaging, Pharmacokinetics, and Changes in Imaging After Treatment
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.
- Conditions
- Malignant Solid Tumor, Oncology
- Being tested
- GEH200520 Injection / GEH200521 (18F) Injection - Part A, Dynamic and Static - PET/CT scan, GEH200520 Injection / GEH200521 (18F) Injection - Part B, Static - PET/CT scan
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GEH200520 Injection / GEH200521 (18F) Injection - Part ADrug
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 scanDiagnostic 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 BDrug
Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush
Static - PET/CT scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1 - 1 mg dose | Experimental | 1 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| Part A Cohort 2 - 2 mg dose | Experimental | 2 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| Part A Cohort 3 - 4 mg dose | Experimental | 4 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| Part A Cohort 4 - 8 mg dose | Experimental | 8 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| 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 Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| 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 Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A; Diagnostic Test: Dynamic and Static - PET/CT scan |
| 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 Receives: Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part B; Diagnostic Test: Static - PET/CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: The incidence of AEs upon causality to the IMPs.
Measured: 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.
Measured: 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.
Measured: Part B: 50 days
Secondary outcomes (35)
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs
Measured: 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.
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 50 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start27 Jan 2023
- Primary completion4 Aug 2026
- Study completion4 Aug 2026
Why it stopped: GE-269-001 Part A in cancer patients was completed. Part B was significantly delayed due to slow recruitment and terminated early. This decision does not affect the Sponsor's continued commitment to advancing PET oncology diagnostics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ravi Karra, MD, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629689
- Sponsor's protocol ID
- GE-269-001
- Other IDs
- 2024-515218-42-00
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2022
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b, Multi-Centre, Open-Label, Dose-Escalation and Dose-Expansion Study in Patients With Solid Tumour Malignancies to Evaluate GEH200520 Injection / GEH200521 (18F) Injection Safety and Tolerability, PET Imaging, Pharmacokinetics, and Changes in Imaging After Treatment
- ClinicalTrials.gov ID
- NCT05629689
- Acronym / sponsor ID
- GE-269-001
- Conditions
- Malignant Solid Tumor, Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: GE-269-001 Part A in cancer patients was completed. Part B was significantly delayed due to slow recruitment and terminated early. This decision does not affect the Sponsor's continued commitment to advancing PET oncology diagnostics.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- 4 Aug 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1 - 1 mg dose | Experimental | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scan1 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 2 - 2 mg dose | Experimental | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scan2 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 3 - 4 mg dose | Experimental | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scan4 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 4 - 8 mg dose | Experimental | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scan8 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 | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scan12 or 15 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together |
| Part A Cohort 6 - Optimal dose | Experimental | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part A, Diagnostic Test: Dynamic and Static - PET/CT scanSelected (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 | Drug: GEH200520 Injection / GEH200521 (18F) Injection - Part B, Diagnostic Test: Static - PET/CT scanSelected (optimal) dose of GEH200520 Injection from Part A with fixed dose of GEH200521 (18F) Injection administered together in 3 sequential repeat imaging visits |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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 female, ≥18 years of age.
- Subject has a life expectancy ≥12 weeks.
- Subject has Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subject has an unresectable or metastatic solid tumour or a local and resectable head and neck squamous cell carcinoma, or an unresectable stage III-IV melanoma.
Key exclusion criteria (20 listed)
- Subject is unable to undergo all procedures in the study and/or is unable to remain still and tolerate the imaging procedure.
- Subject has 12-lead ECG significant findings during screening, per Investigator's assessment.
- Subject is not stable due to medical condition or therapy that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
- Subject has active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents.
- Subject has serious non-malignant disease or conditions that, in the opinion of the Investigator, could compromise subject safety or protocol objectives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GEH200520 Injection / GEH200521 (18F) Injection - Part AAdministration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush | Drug | Part A Cohort 1 - 1 mg dose, Part A Cohort 2 - 2 mg dose, Part A Cohort 3 - 4 mg dose, Part A Cohort 4 - 8 mg dose, Part A Cohort 5 (optional) - 12 or 15 mg dose, Part A Cohort 6 - Optimal dose |
| Dynamic and Static - PET/CT scanDynamic 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. | Diagnostic test | Part A Cohort 1 - 1 mg dose, Part A Cohort 2 - 2 mg dose, Part A Cohort 3 - 4 mg dose, Part A Cohort 4 - 8 mg dose, Part A Cohort 5 (optional) - 12 or 15 mg dose, Part A Cohort 6 - Optimal dose |
| GEH200520 Injection / GEH200521 (18F) Injection - Part BAdministration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush | Drug | Part B |
| Static - PET/CT scanWhole-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. | Diagnostic test | Part B |
Primary outcome
Part A: The incidence of AEs upon causality to the IMPs.
Time frame: 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.
Time frame: 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.
Time frame: Part B: 50 days
35 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs, for Part A subjects.
Time frame: 7 days
Changes in physical examination status following administration of GEH200520 and GEH200521 (18F) for Part A subjects
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 7 days
Collection of the incidence, severity, changes between visits for AEs/SAEs/AESIs
Time frame: 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.
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 50 days
Changes in physical examination status following administration of GEH200520 and GEH200521 (18F) for Part B subjects
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Baseline, Day 15, Day 36, Day 50
Changes in blood pressure in mmHg following administration of GEH200520 and GEH200521 (18F) for Part B subjects
Time frame: Baseline, Day 15, Day 36, Day 50
Changes in temperature as degree C following administration of GEH200520 and GEH200521 (18F) for Part B subjects
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 50 days
Results and safety
The study was stopped early (reason given: GE-269-001 Part A in cancer patients was completed. Part B was significantly delayed due to slow recruitment and terminated early. This decision does not affect the Sponsor's continued commitment to advancing PET oncology diagnostics.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Karra, MD study director
GE Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GEH200520 Injection / GEH200521 (18F) Injection - Part A, Dynamic and Static - PET/CT scan and GEH200520 Injection / GEH200521 (18F) Injection - Part B in people with Malignant Solid Tumor and Oncology, run by GE Healthcare at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: GE-269-001 Part A in cancer patients was completed. Part B was significantly delayed due to slow recruitment and terminated early. This decision does not affect the Sponsor's continued commitment to advancing PET oncology diagnostics.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: The incidence of AEs upon causality to the IMPs. (time frame: Part A: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.