Study of [68Ga]-NeoBOMB1 imaging in patients with malignancies known to overexpress GRPR

Phase 1

• Conditions: Malignancies known to overexpress Gastrin-Releasing Peptide Receptors; MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10061873 Term: Non-small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10041067 Term: Small cell lung cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-003432-37-AT
• Lead Sponsor: Advanced Accelerator Applications International SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-17
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

•Subjects must be at least 18 years of age
•Subjects must have signed and dated an informed consent prior to any study-specific procedures.
•Subjects with histologically-confirmed tumour, for whom a less than 6-month-old biopsy has been performed.
•Dosimetry group:
-Luminal breast cancer
-Adenocarcinoma of the prostate
•Non-dosimetry group:
-Luminal breast cancer
-Adenocarcinoma of the prostate
-Small-cell lung cancer
-Non-small cell lung cancer
-Colorectal carcinoma
•At least one malignant lesion detected via functional or morphological imaging (PET combined to appropriate tracer according to tumour type, CT, MRI) within 3 months prior to the administration of [68Ga]-NeoBOMB1.
•The Eastern Cooperative Oncology (ECOG) performance status 0-2.
•Subjects must agree to use highly effective methods of contraception (female partners of male participants should use highly effective methods of contraception) during the trial.

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 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73 m2.
•Haematological toxicity grade > 2 (Toxicity Grading Scale in vaccine clinical trials)
•Participation in any other investigational trial within 30 days of study entry.
•Subjects with positive pregnancy test (Urine dipstick), and/or currently breast-feeding
•Concurrent severe illness or clinically relevant trauma within 2 weeks before the administration of the investigational product that might preclude study completion or interfere with study results.
•Concurrent bladder outflow obstruction or unmanageable urinary incontinence.
•Known or expected hypersensitivity to 68Gallium, NeoBOMB1, or any excipient present in [68Ga]-NeoBOMB1.
•Any condition that precludes raised arms position
•Prior administration of a radiopharmaceutical within a period corresponding to 8 half-lives of the radionuclide.
•History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.

Study & Design

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