[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR) (NeoFIND)

Advanced Accelerator Applications

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer; Small Cell Lung Cancer; Non Small Cell Lung Cancer; Prostate Cancer; Colorectal Cancer

Treatments: Drug: [68Ga]-NeoBOMB1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03724253

A005D-E01-201

CAAA503A12201 (Other Identifier)

2017-003432-37 (EudraCT Number)

Details and patient eligibility

About

This was a Phase II, multi-center, open label, single dose study in patients with tumor types known to overexpress Gastrin-Releasing Peptide Receptor (GRPR), including breast, prostate, colorectal, Non-Small Cell Lung Cancer (NSCLC) and Small-Cell Lung Cancer (SCLC).

Full description

A total of 50 subjects were planned for the study (10 subjects for the dosimetry group and 40 subjects for the non dosimetry group). In total, 22 subjects were screened for eligibility and 19 subjects were enrolled (2 subjects in the dosimetry group and 17 subjects in the non dosimetry group).

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 tumor for whom a recent biopsy (not older than 6-months old) 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 tumor type, CT, MRI) within 3 months prior to [68Ga]-NeoBOMB1 administration
• 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 eGFR <50 ml/min/1.73m2
• hematological 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 [68Ga]-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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Phase II dosimetry group

Experimental group

Description:

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

Treatment:

Drug: [68Ga]-NeoBOMB1

Phase II non-dosimetry group

Experimental group

Description:

All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].

Treatment:

Drug: [68Ga]-NeoBOMB1