Phase I/IIa study to evaluate 68GaNOTA-anti-MMR-VHH2, a new tracer for positron emission tomografic imaging (PET/CT scan) of macrophages in tumor lesions.

Phase 1

• Conditions: Tumour associated macrophages found in tumour lesions of two cancer types: breast cancer or melanoma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-001471-23-BE
• Lead Sponsor: Z Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-17
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Part I
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
- Patient 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.

Part II
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:
oTriple-negative breast carcinoma
oHormone-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
oMelanoma
-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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 21

Exclusion Criteria

Part I
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified