Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04168528
Other study ID # UZBRU_VHH2_1
Secondary ID 2017-001471-23
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 5, 2019
Est. completion date December 2024

Study information

Verified date January 2024
Source Universitair Ziekenhuis Brussel
Contact UZ Brussel
Phone +3224776013
Email nucgmail@uzbrussel.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 37
Est. completion date December 2024
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
68GaNOTA-Anti-MMR-VHH2
Injection of the radiopharmaceutical and PET/CT imaging

Locations

Country Name City State
Belgium Uz Brussel Brussels

Sponsors (2)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel Kom Op Tegen Kanker

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A