Actively Recruiting
A Phase 1a/1b Study to Evaluate Safety, Tolerability, and PET Imaging of GEH200520 and GEH200521 (18F) Injections in Patients With Solid Tumour Cancers
Led by GE Healthcare · Updated on 2025-11-17
50
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and imaging quality of two investigational drugs, GEH200520 and GEH200521 (18F), in patients with solid tumor cancers. The study includes patients who have unresectable or metastatic solid tumors, certain head and neck cancers, or advanced melanoma, and who are eligible for immune-checkpoint inhibitor (ICI) treatment. This phase 1a/1b trial is designed to understand how these drugs behave in the body and how they may change imaging results after ICI treatment. The study is divided into two parts: Part A focuses on assessing safety and determining the appropriate dose of GEH200520 combined with a fixed dose of GEH200521 (18F) through several dose levels. Participants receive the drug injections followed by PET/CT scans at various time points, including dynamic and static imaging up to 24 hours post-injection. Part B evaluates the imaging quality, safety, and tolerability of the selected optimal dose in patients undergoing immunotherapy, with multiple imaging visits before and after treatment, and additional follow-up scans. Participants will complete several study visits including screening, imaging sessions, immunotherapy treatment visits, and follow-up assessments over periods ranging from about 21 days in Part A to approximately 64 days in Part B. During the study, researchers will monitor adverse events, vital signs, laboratory tests, electrocardiograms, pharmacokinetics, and immunogenicity. Imaging results will be compared to tumor biopsy findings and standard CT or FDG scans. Safety and tolerability will be closely observed throughout and after drug administration.
CONDITIONS
Brief Title
A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to follow all study procedures and provide informed consent
- Male or female aged 18 years or older
- Life expectancy of at least 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Diagnosis of unresectable or metastatic solid tumour, local and resectable head and neck squamous cell carcinoma, or unresectable stage III-IV melanoma
- Eligible for immune-checkpoint inhibitor (ICI) treatment as judged by the investigator
- At least one measurable tumour lesion documented by CT or MRI within the last 12 months
- Tumour lesion(s) suitable for safe biopsy according to standard clinical care
- Agree to follow protocol contraception methods if applicable
You will not qualify if you...
- Unable to undergo all study procedures or remain still for imaging
- Significant ECG findings during screening as assessed by investigator
- Unstable medical condition or therapy compromising safety or study goals
- Active or history of autoimmune disease requiring systemic steroids or immunosuppressants
- Serious non-cancer diseases or conditions compromising safety or study goals
- Presence of B or T cell lymphoma
- Brain or bone marrow metastases compromising safety
- Signs or symptoms of systemic infection within 2 weeks prior to imaging
- History of severe allergic or hypersensitivity reactions to antibodies, fusion proteins, or study drug ingredients
- Any other disease or condition contraindicating use of ICI or affecting results interpretation
- Laboratory values outside protocol-defined ranges compromising safety
- Major surgery within 4 weeks prior to enrollment
- Participation in another interventional clinical study within 30 days prior to screening (except site IIS)
- Pregnant, planning pregnancy, or breastfeeding
- History of alcohol or drug abuse within last year
- Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives prior to dosing
- Treatment with systemic immunosuppressive medications within 2 weeks prior to dosing
- Use of acute low-dose systemic immunosuppressants compromising study goals
- Use of systemic corticosteroids for inflammatory or autoimmune symptoms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days for Part A; 50 days for Part B
Participants receive injections of GEH200520 and GEH200521 (18F) followed by PET/CT scans to evaluate safety, tolerability, and imaging characteristics.
Multiple imaging visits including up to 3 sequential PET/CT scans in Part B
Duration - 7 days for Part A; 50 days for Part B
Participants are monitored for adverse events, pharmacokinetics, and changes in physical and laboratory assessments after injections and imaging visits.
Follow-up assessments at baseline, 24 hours, 7 days for Part A; baseline, Day 15, Day 36, and Day 50 for Part B
Trial Site Locations
Total: 2 locations
1
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
2
UMC Groningen
Groningen, Netherlands
Actively Recruiting
Research Team
Y
Yaron Raiter, MD
S
Shoma Das
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
7
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