Clinical trial · Interventional
[68Ga]-NeoBOMB1 Imaging in Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
Phase II Study of Preliminary Diagnostic Performance of [68Ga]-NeoBOMB1 in Adult Patients With Malignancies Known to Overexpress Gastrin Releasing Peptide Receptor (GRPR)
NCT03724253CI-TRIAL-00047876NeoFINDterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment was stopped before the target sample size was achieved.
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [68Ga]-NeoBOMB1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Phase II dosimetry group
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- interventionNames
- Drug: [68Ga]-NeoBOMB1
- type
- EXPERIMENTAL
- label
- Phase II non-dosimetry group
- description
- All eligible participants were to receive recommended dose of \[68Ga\]-NeoBOMB1 of 3 Mega Becquerel (MBq)/Kg (+/- 10%) \[but not more than 250 and not less than 150 MBq. The maximum peptide mass administered was 50 microgram (µg)\].
- interventionNames
- Drug: [68Ga]-NeoBOMB1
Primary outcomes (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.