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

NCT04168528 | Completed Phase 1 DMC

• 2 other identifiers: UZBRU_VHH2_12017-001471-23
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

Uz Brussel

Brussels, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Breast Neoplasms; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Study Officials

• Tony LAHOUTTE, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 19, 2019
• Study Start: November 5, 2019
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)