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

NCT03724253 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: A005D-E01-2012017-003432-37CAAA503A12201
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 3

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).

Conditions

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

Keywords

[68Ga]-NeoBOMB1

Outcome Measures

Primary Outcomes (8)

• Number of Lesions Detected by [68Ga]-NeoBOMB1

  The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the number of lesions identified by Positron Emission Tomography (PET) overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

• Number of Participants With Lesions Detected by [68Ga]-NeoBOMB1 Per Location

  The preliminary targeting properties of \[68Ga\]-NeoBOMB1 were to be assessed by summarizing the location of lesions identified by PET overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

• Non-Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location

  Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

• Non-Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

  Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.05 (only applicable for the Prostate Group), 1.50 and 2.50 hours)

• Dosimetry Group: Standard Uptake Value (SUV) Mean by Timepoint and Lesion Location

  Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

• Dosimetry Group: Standard Uptake Value (SUV) Max by Timepoint and Lesion Location

  Targeting properties of \[68Ga\]-NeoBOMB1 were to be evaluated by semi-quantitatively assessing radiotracer uptake at lesion level, identified via PET Imaging. The SUVmean and SUVmax (g/mL) of each lesion were to be calculated and reported by lesion location with summary statistics at all imaging time points. SUV was to be calculated overall and split by GRPR positive and negative patients, as well as by tumor type. Only descriptive analysis performed.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

• Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Tumors

  For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching tumor lesions was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

• Dosimetry Group: Evaluation of Percentage of Injected Dose Reaching the Target (TACs) in Organs

  For patients included in the dosimetry group, the percentage of injected dose per gram of tissue (%ID/g) reaching source organs was to be calculated using the acquired PET images at each time point. The resulting TACs were to be summarized descriptively.

  [68Ga]-NeoBOMB1 PET imaging acquired at Day 1 (0.15, 1.00, 2.00 and 4.00 hours)

Secondary Outcomes (16)

• Treatment Emergent Adverse Events Profile

  From first dosing (single administration, Day 1) up to last follow-up visit or until the event has resolved to baseline grade or better or the event was assessed stable by the investigator or the patient was lost to follow-up or withdrew consent.

• Number of Lesions Detected by Conventional Imaging

  Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

• Number of Participants With Lesions Detected by Conventional Imaging Per Location

  Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

• Lesion-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging

  Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

• Patient-level Analyses of Diagnostics by [68Ga]-NeoBOMB1 Compared With Conventional Imaging

  Conventional imaging collected within 3 months prior to study entry up to [68Ga]-NeoBOMB1 PET imaging acquired at Day 1

Study Arms (2)

Phase II dosimetry group

EXPERIMENTAL

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

Drug: [68Ga]-NeoBOMB1

Phase II non-dosimetry group

EXPERIMENTAL

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

Drug: [68Ga]-NeoBOMB1

Interventions

[68Ga]-NeoBOMB1 DRUG

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

Phase II dosimetry group; Phase II non-dosimetry group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Advanced Accelerator Applications: lead

Study Sites (3)

Medical University Innsbruck Department of Nuclear Medicine

Innsbruck, Austria

Location

University of Grenoble - Hopital Michallon, Service de Medicine Nucleaire

La Tronche, France

Location

University of Bordeaux, Unite TEP RECHERCHE - Hopital Xavier Arnozan

Pessac, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Recruitment was stopped before the target sample size was achieved..

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study design included a dosimetry and non-dosimetry groups and with the following tumor types: * Breast Cancer: dosimetry and non-dosimetry groups * Prostate Cancer: dosimetry and non-dosimetry groups * Colorectal cancer: non-dosimetry group * Non-Small Cell Lung Cancer (NSCLC): non-dosimetry group * Small-Cell Lung Cancer (SCLC): non-dosimetry group All data presentations were to be presented primarily by the overall population but were also to be repeated split by tumor type where relevant. Some presentations were also to be repeated split by whether or not the patient was found to have tumors bearing GRPR expression according to cytology and/or histopathology findings.

Study Record Dates

• First Submitted: October 21, 2018
• First Posted: October 30, 2018
• Study Start: July 3, 2018
• Primary Completion: June 20, 2019
• Study Completion: July 5, 2019
• Last Updated: October 23, 2020
• Results First Posted: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); FR (2)