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

NCT ID: NCT03724253

Last Updated: 2020-10-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2019-07-05

Brief Summary

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).

Detailed 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Phase II dosimetry group

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

Group Type: EXPERIMENTAL

[68Ga]-NeoBOMB1

Intervention Type: DRUG

\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors

Phase II non-dosimetry group

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

Group Type: EXPERIMENTAL

[68Ga]-NeoBOMB1

Intervention Type: DRUG

\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors

Interventions

[68Ga]-NeoBOMB1

\[68Ga\]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Advanced Accelerator Applications

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Medical University Innsbruck Department of Nuclear Medicine

Innsbruck, , Austria

University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire

La Tronche, , France

University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan

Pessac, , France

Countries

Austria; France

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2017-003432-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAAA503A12201

Identifier Type: OTHER

Identifier Source: secondary_id

A005D-E01-201

Identifier Type: -

Identifier Source: org_study_id