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A Study to Evaluate GEH200520/GEH200521 (18F) Safety and Tolerability When Used for PET Scans in Patients With Solid Tumour Malignancies

ConditionsMalignant Solid TumorOncology
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGE Healthcare

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

50 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Part A Cohort 1 - 1 mg doseExperimental treatment 2 interventions
Group B: Part A Cohort 2 - 2 mg doseExperimental treatment 2 interventions
Group C: Part A Cohort 3 - 4 mg doseExperimental treatment 2 interventions
Group D: Part A Cohort 4 - 8 mg doseExperimental treatment 2 interventions
Group E: Part A Cohort 5 (optional) - 12 or 15 mg doseExperimental treatment 2 interventions
Group F: Part A Cohort 6 - Optimal doseExperimental treatment 2 interventions
Group G: Part BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A: The incidence of AEs upon causality to the IMPs.

Time frame
Part A: 7 days
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GE Healthcare

Lead sponsor

Source ClinicalTrials.gov
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