Phase II study of preliminary diagnostic performance of [68Ga]-NeoBOMB1 in adult patients with malignancies known to overexpress Gastrin Releasing Peptide Receptor

Phase 2

Conditions: Cancer
Malignancies known to overexpress GRPR
10027655

Registration Number: NL-OMON46627

Lead Sponsor: Advanced Accelerator Applications International S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 10

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.

Exclusion Criteria

• Renal insufficiency or an estimated Glomerular Filtration Rate (eGFR) <50 ml/min/1.73m2..
• 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Study Endpoint<br /><br>•Number and location of tumour lesions detected by [68Ga]-NeoBOMB1 overall and<br /><br>for<br /><br>each tumour type<br /><br>•Calculation of the ratio tumour/background SUV and calculation of percentage<br /><br>absorbed dose in tumour overall and for each tumour type.</p><br>

Secondary Outcome Measures