Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369831
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-09
Brief Title:
HER2 Targeted Molecular Imaging in MBC Using 68Ga-ABS011
Sponsor:
ABSCINT NVSA
Organization:
ABSCINT NVSA
Study Overview
Official Title:
Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 HER2 Targeted Positron Emission Tomography and Computed Tomography PETCT with 68Ga-ABS011 in Metastatic Breast Cancer mBC
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HERMIA
Brief Summary:
This phase II study aims to confirm the diagnostic performance and accuracy of 68Ga-ABS011 PETCT in determining the HER2 expression status and to evaluate 68Ga-ABS011s ability to drive changes in therapeutic treatment 68Ga-ABS011 will be compared to the current standard of care SOCa diagnostic methods including immunohistochemistry IHC in situ hybridization ISH and imaging tools used for treatment response follow-up including Fluorodeoxyglucose F-18 18F-FDG positron emitted tomography PET and contrast enhanced computed tomography ceCT
Detailed Description:
Lesion sampling error resulting tumor heterogeneity is probably the biggest pitfall when determining the HER2 status Moreover IHC expression or gene amplification can be affected by procedural differences and sample handling differences that are influenced by the experience and training of the pathologists team Last but not least immunohistochemistry interpretation remains a semiquantitative subjective scoring which is susceptible to considerable interobserver variability
68Ga-ABS011 is a NOTA chelating agent to label sdAbs with radionuclides linked single domain antibody sdAb with the capability to bind HER2 tumor antigens very fast while the unbound fraction is rapidly cleared from the blood ABS011 is labeled with gallium-68 a short-lived isotope 68Ga t12 68 min Combining rapid targeting of HER2 fast clearance and low radiation burden make 68Ga-ABS011 is suited for specific tumor marker whole body PETCT imaging The available preclinical and clinical results with 68Ga-ABS011 or its first generation product including a phase I and a phase II clinical trials did not reveal any safety signals Extended safety assessments including anti-drug antibody ADA serum evaluations after 2 consecutive administrations supported the previously observed low immunogenicity risk profile with these sdAbs Besides safety this tracer showed potential in the assessment of inter-lesional HER2 expression heterogeneity and also displayed some higher sensitive and more specific determination of disease extent compared to 18F-FDG
Whole body mapping of HER2 an antigen present in multiple cancer types might I Reduce tumor lesion sampling errors and resultingly reduce false negative HER2 IHC outcomes potentially broadening the therapeutic and interventional treatment options for the patient II Enable identification of inter-and intratumor heterogeneity and III Support follow-up of HER2 targeted treatment response and accompanied treatment decisions
68Ga-ABS011 is a NOTA chelating agent to label sdAbs with radionuclides linked single domain antibody sdAb with the capability to bind HER2 tumor antigens very fast while the unbound fraction is rapidly cleared from the blood ABS011 is labeled with gallium-68 a short-lived isotope 68Ga t12 68 min Combining rapid targeting of HER2 fast clearance and low radiation burden make 68Ga-ABS011 is suited for specific tumor marker whole body PETCT imaging The available preclinical and clinical results with 68Ga-ABS011 or its first generation product including a phase I and a phase II clinical trials did not reveal any safety signals Extended safety assessments including anti-drug antibody ADA serum evaluations after 2 consecutive administrations supported the previously observed low immunogenicity risk profile with these sdAbs Besides safety this tracer showed potential in the assessment of inter-lesional HER2 expression heterogeneity and also displayed some higher sensitive and more specific determination of disease extent compared to 18F-FDG
Whole body mapping of HER2 an antigen present in multiple cancer types might I Reduce tumor lesion sampling errors and resultingly reduce false negative HER2 IHC outcomes potentially broadening the therapeutic and interventional treatment options for the patient II Enable identification of inter-and intratumor heterogeneity and III Support follow-up of HER2 targeted treatment response and accompanied treatment decisions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-511419-22-00 | CTIS | None | None |