Phase I/IIa Study of 68GaNOTA-Anti-MMR-VHH2 for PET/CT | NCT04168528

NCT04168528

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2017-001471-23	EudraCT Number

Status Module

Name	Class
Kom Op Tegen Kanker	OTHER

Label	Type	Description	Intervention Names
Part I: safety, tolerability, biodistribution and dosimetry	Experimental	Phase I	Drug: 68GaNOTA-Anti-MMR-VHH2
Part II: tumor targeting potential and correlation to IHC	Experimental	Phase II	Drug: 68GaNOTA-Anti-MMR-VHH2

Name	Type	Description	Arm Group Labels	Other Names
68GaNOTA-Anti-MMR-VHH2	Drug	Injection of the radiopharmaceutical and PET/CT imaging	Part I: safety, tolerability, biodistribution and dosimetry Part II: tumor targeting potential and correlation to IHC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability and safety of 68GaNOTA-Anti-MMR-VHH2: reported as type, frequency and severity (graded according to the CTCAEv5) (Part I).	Assessed using physical examination and blood sampling for hematology and clinical chemistry.	Before injection up until 6 hrs after injection
Human biodistribution using blood sampling and PET/CT imaging: reported as relative uptake values per organ at 10, 90 and 150 minutes per individual subject and as a mean over all subjects (Part I).	Measured in standard uptake values in PET/CT imaging and expressed in relation to the injected activity.	Immediately after injection up to 3 hrs after injection
Human dosimetry using PET/CT imaging data: radiation dose to individual organs and the equivalent dose for the whole body of each subject and as a mean over all subjects (Part I).	Dosimetry will be calculated using the OLINDA software.	10 min up to 3 hrs after injection
Tumor targeting potential using PET/CT and correlation to immunohistological MMR staining after resection: assessed using correlation coefficient (Part II).	PET/CT and immunohistochemistry will be assessed using a semi-quantitative scale.	Resection of lesion up to 14 days after PET/CT

Eligibility Module

Eligibility Criteria

PART I:

Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

Patients who have given informed consent
Patients at least 18 years old
Patients with local, locally advanced or metastatic disease of a malignant solid tumor. In order to minimize partial volume effect the diameter of at least 1 tumor lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.

Exclusion Criteria:

Patients will not be included in the study if one of the following criteria applies:

Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
Pregnant patients
Breast feeding patients
Patients with abnormal liver (Bilirubin ≥1.5 x ULN, ALT (SGPT) ≥3 x ULN) or kidney function (Serum creatinine clearance ≤50 ml/min as calculated with Cockcroft-Gault formula)
Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
Patients with any serious active infection
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
Patients who cannot communicate reliably with the investigator
Patients who are unlikely to cooperate with the requirements of the study
Patients who are unwilling and/or unable to give informed consent
Patients at increased risk of death from a pre-existing concurrent illness
Patients who participated already in this study

PART II:

Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

Patients who have given informed consent
Patients at least 18 years old
Patients diagnosed with a local, locally advanced or metastatic disease, with any of the following cancer types :
Triple-negative breast carcinoma,
Hormone-receptor negative (HR-), HER2+ breast carcinoma, with HER2-expression defined as HER2+ on ISH or 3+ on IHC, as determined by local assessment on any of the available cancer tissues
Melanoma
Patients who have had a biopsy of at least one lesion or who are planned to undergo standard-of-care resection or biopsy of at least one lesion, in order to minimize partial volume effect, the diameter of that lesion should be ≥ 10 mm in short axis for invaded adenopathies and ≥ 10 mm in long axis for all other types of lesions.

Exclusion Criteria:

Patients will not be included in the study if one of the following criteria applies:

Eastern Cooperative Oncology Group (ECOG) performance status 3 or higher
Pregnant patients
Breast feeding patients
Patients with recent (< 1 week) gastrointestinal disorders (CTCAE v4.0 grade 3 or 4) with diarrhea as major symptom
Patients with any serious active infection
Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the test radiopharmaceutical
Patients who cannot communicate reliably with the investigator
Patients who are unlikely to cooperate with the requirements of the study
Patients who are unwilling and/or unable to give informed consent
Patients at increased risk of death from a pre-existing concurrent illness
Patients who participated already in this study

ID	Term
D001943	Breast Neoplasms
D008545	Melanoma