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

NCT ID: NCT04168528

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-05
• Study Completion Date: 2024-12-04

Brief Summary

Phase I study to evaluate the human safety and tolerability, biodistribution and dosimetry of 68GaNOTA-Anti-MMR-VHH2

Phase IIa study to evaluate tumour uptake of 68Ga-NOTA-anti-MMR-VHH2 in patients with breast cancer or melanoma. To correlate uptake of 68Ga-NOTA-anti-MMR-VHH2 in cancer lesions to immunohistological MMR staining after resection or biopsy of the same lesion.

Conditions

Malignant Solid Tumor; Breast Cancer; Melanoma (Skin)

Keywords

PET/CT; MMR-PET/CT; Macrophage PET/CT

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Part I: safety, tolerability, biodistribution and dosimetry

Phase I

Group Type: EXPERIMENTAL

68GaNOTA-Anti-MMR-VHH2

Intervention Type: DRUG

Injection of the radiopharmaceutical and PET/CT imaging

Part II: tumor targeting potential and correlation to IHC

Phase II

Group Type: EXPERIMENTAL

68GaNOTA-Anti-MMR-VHH2

Intervention Type: DRUG

Injection of the radiopharmaceutical and PET/CT imaging

Interventions

68GaNOTA-Anti-MMR-VHH2

Injection of the radiopharmaceutical and PET/CT imaging

Intervention Type: DRUG

Eligibility Criteria

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.

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 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:

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kom Op Tegen Kanker

OTHER

Sponsor Role: collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tony LAHOUTTE, MD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Uz Brussel

Brussels, Brussels Capital, Belgium

Countries

Belgium

Other Identifiers

2017-001471-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

UZBRU_VHH2_1

Identifier Type: -

Identifier Source: org_study_id