A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
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
2 other identifiers
interventional
50
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2023
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedStudy Start
First participant enrolled
January 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 10, 2029
November 17, 2025
November 1, 2025
6.1 years
October 11, 2022
November 14, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
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.
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.
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.
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.
7 days
- +30 more secondary outcomes
Study Arms (7)
Part A Cohort 1 - 1 mg dose
EXPERIMENTAL1 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together
Part A Cohort 2 - 2 mg dose
EXPERIMENTAL2 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together
Part A Cohort 3 - 4 mg dose
EXPERIMENTAL4 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together
Part A Cohort 4 - 8 mg dose
EXPERIMENTAL8 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
EXPERIMENTAL12 or 15 mg mass dose of GEH200520 Injection with fixed dose of GEH200521 (18F) Injection administered together
Part A Cohort 6 - Optimal dose
EXPERIMENTALSelected (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
EXPERIMENTALSelected (optimal) dose of GEH200520 Injection from Part A with fixed dose of GEH200521 (18F) Injection administered together in 3 sequential repeat imaging visits
Interventions
Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush
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.
Administration of GEH200520 Injection followed within 2 to 4 minutes by GEH200521 (18F) Injection followed by a 10mL saline flush
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (2)
Amsterdam UMC
Amsterdam, Netherlands
UMC Groningen
Groningen, Netherlands
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Yaron Raiter, MD
GE Healthcare
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2022
First Posted
November 29, 2022
Study Start
January 27, 2023
Primary Completion (Estimated)
March 10, 2029
Study Completion (Estimated)
March 10, 2029
Last Updated
November 17, 2025
Record last verified: 2025-11