68GA-NOTA-ABSCINT-HER2 for Metastatic breast cancer | Other metastatic solid carcinoma

Inclusion criteria

• {"criterion_text":"- 1.\tAdult (≥ 18 years at the time of informed consent signature) male or female patient\n- 2.\tPatient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).\n- 3.\tPatients with documented hormone receptor positive/HER2 negative, triple-negative or HER2 positive mBC that could become eligible for commercially available HER2 targeted monotherapy (i.e. through confirmation of HER2 IHC non-0 status assessed during the course of the study).\n- 4.\tPatient presenting with at least one target biopsiable, FDG positive , non-liver metastatic lesion of ≥15 mm defined on ceCT (as part of screening 18F-FDG PET/ceCT assessment).\n- 5.\tPatient willing to undergo at least one tumor biopsy.\n- 6.\tMale patients able to father children and female patients of childbearing potential agree to use effective methods of contraception during the diagnostic and SOCa treatment follow-up study phases.\n- 7.\tEastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.\n- 8.\tAbility and willingness of the research participant to provide written informed consent.\n- 9.\tSame inclusion criteria are applicable for (non-BC) metastatic solid carcinoma subjects, with the difference that a recent historical 18F-FDG PET/(ce)CT scan performed as per standard of care may also be used to support eligibility assessment, provided it is not older than 1 month prior to screening. If no such scan is available within this timeframe, a new scan should be performed as part of standard of care."}

Exclusion criteria

• {"criterion_text":"- 1.\tPrimary (non-metastatic) breast cancer.\n- 6.\tLife expectancy lower than 3 months.\n- 7.\tPregnancy or breastfeeding.\n- 8.\tInadequate organ function, suggested by clinically relevant abnormal laboratory results: a.\tSignificantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2. b.\tTotal bilirubin ≤1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). c.\tAspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >5.0 x ULN.\n- 9.\tPatients with a known hypersensitivity to any of the IMP components or packaging.\n- Same exclusion criteria are applicable for (non-BC) metastatic solid carcinoma subjects, except for exclusion# 3: no 18F-FDG PET/ceCT must be completed as part of the screening visit. A recent historical 18F-FDG PET/(ce)CT scan performed as per standard of care may also be used to support eligibility assessment, provided it is not older than 1 month prior to screening. If no such scan is available within this timeframe, a new scan should be performed as part of standard of care.\n- 10.\tPatients with increased risks of bleeding or other complications from biopsies (e.g. patients under anticoagulation therapy for whom temporary discontinuation of this therapy cannot be safely performed).\n- 11.\tPatients with a known hypersensitivity or contraindication for iodinated contrast media (iCM) which cannot be controlled by taking prophylactic measures (e.g. temporary treatment interruption or introduction of adequate pre-medication).\n- 12.\tPatients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).\n- 13.\tAny condition that in the opinion of the investigator may significantly interfere with study compliance (including but not limited to psychological or psychiatric, social or geographical condition potentially hampering compliance with the study requirements).\n- 2.\tPatient not willing to undergo at least one tumor biopsy.\n- 3.\t18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.\n- 4.\tMetastatic setting 18F-FDG PET/ceCT indicating that the identified tumor lesions cannot be biopsied due their location and/or tissue type and/or an increased risk for serious comorbidities.\n- 5.\tBrain and liver metastases are the sole sites of metastatic disease."}

Primary endpoints

• {"endpoint_text":"- 1.Evaluation, on a per-IHC (and ISH) lesion level(I), of the diagnostic performance of 68Ga-ABS011 PET/CT(III) compared to HER2 IHC status(IV) [2] by means of: -\tPositive % diagnostic agreement -\tNegative % diagnostic agreement -\tOverall % diagnostic agreement","definition_or_measurement_approach":"Diagnostic performance measured per lesion versus HER2 IHC (and ISH) using Positive % diagnostic agreement, Negative % diagnostic agreement and Overall % diagnostic agreement."}

Secondary endpoints

• {"endpoint_text":"- 2.Incidence rate of all adverse events (AEs) and serious AEs (SAEs) from V1 to V5 included, coded using the Medical Dictionary for Regulatory Activities (MedDRA), in terms of System Organ Class (SOC) and Preferred Term (PT).","definition_or_measurement_approach":"Incidence rate of AEs and SAEs from V1 to V5 coded by MedDRA (SOC and PT)."}
• {"endpoint_text":"- 3.Proportion of mBC patients for whom the whole-body 68Ga-ABS011 PET/CT guided biopsy impacted the management of the mBC (driven by a revised IHC/ISH status and/or additional insights in whole-body tumor heterogeneity). If this proportion is at least 17% (1 out of 6 patients), whole body mapping via 68Ga-ABS011 PET/CT would be considered as a tool of high value, introducing clinically relevant changes in diagnostic and therapeutic management of mBC.","definition_or_measurement_approach":"Proportion of mBC patients with management changes attributable to 68Ga-ABS011 PET/CT guided biopsy (threshold of interest ≥17%)."}
• {"endpoint_text":"- 4.1.Positive predictive value of 68Ga-ABS011 using IHC(IV) and ISH(V) as a reference: a.\tProportion of lesions with a HER2 positive 68Ga-ABS011 status and a confirmed HER2 IHC non-0 status. b.\tProportion of lesions with a HER2 positive 68Ga-ABS011 status and a positive ISH status.","definition_or_measurement_approach":"Positive predictive value calculated as proportions of lesions with positive 68Ga-ABS011 and corresponding positive IHC non-0 and positive ISH."}
• {"endpoint_text":"- 4.2.Negative predictive value of 68Ga-ABS011 of 68Ga-ABS011 using IHC(IV) and ISH(V) and as a reference: a.\tProportion of lesions with a negative 68Ga-ABS011 status and a HER2 IHC 0 status. b.\tProportion of lesions with a negative 68Ga-ABS011 status and a negative ISH status.","definition_or_measurement_approach":"Negative predictive value calculated as proportions of lesions with negative 68Ga-ABS011 and corresponding IHC 0 and negative ISH."}
• {"endpoint_text":"- 4.3.Positive and negative likelihood ratio of 68Ga-ABS011 PET/CT using IHC(IV) and ISH(V) as a reference.","definition_or_measurement_approach":"Calculation of positive and negative likelihood ratios versus IHC/ISH reference."}
• {"endpoint_text":"- 5.1.Positive predictive value of 68Ga-ABS011 using 18F-FDG PET/ceCT(VIII) as a reference: a.\tThe proportion of lesions with a HER2 positive 68Ga-ABS011 status and a confirmed MR after 2 cycles of HER2 targeted treatment (6 weeks post-HER2 treatment initiation). b.\tThe proportion of lesions with a HER2 positive 68Ga-ABS011 status and an achieved ETS after 2 cycles of HER2 targeted treatment (6 weeks post-HER2 treatment initiation).","definition_or_measurement_approach":"PPV vs 18F-FDG PET/ceCT assessed by proportion of lesions with HER2 positive 68Ga-ABS011 and confirmed metabolic response (MR) or early tumor shrinkage (ETS) after 2 cycles (6 weeks)."}
• {"endpoint_text":"- 5.2.Negative predictive value of 68Ga-ABS011 of 68Ga-ABS011 using 18F-FDG PET/ceCT(VIII) as a reference. a.\tProportion of lesions with a negative 68Ga-ABS011 status confirmed by absence of MR (non-MR) after 2 cycles of HER2 targeted treatment (6 weeks post-HER2 treatment initiation). b.\tProportion of lesions with a negative 68Ga-ABS011 status that did not achieve ETS after 2 cycles of HER2 targeted treatment (6 weeks post-HER2 treatment initiation).","definition_or_measurement_approach":"NPV vs 18F-FDG PET/ceCT assessed by proportions of lesions with negative 68Ga-ABS011 and absence of MR or ETS after 2 cycles (6 weeks)."}
• {"endpoint_text":"- 5.3.Positive and negative likelihood ratio of 68Ga-ABS011 PET/CT using 18F-FDG PET/ceCT(VIII) as a reference.","definition_or_measurement_approach":"Calculation of positive and negative likelihood ratios versus 18F-FDG PET/ceCT reference."}
• {"endpoint_text":"- 5.4.Assessment for all individual evaluable lesions(II), between 68Ga-ABS011 PET/CT HER2 status and treatment response assessed on 18F-FDG PET/ceCT(VIII) completed at screening and after 2 cycles of HER2 targeted treatment by means of: Assessment for all individual evaluable lesions(II), of the positive, negative and overall agreement between 68Ga-ABS011 PET/CT HER2 status and treatment response; i.e., Metabolic Response (MR) and Early Tumor Shrinkage (ETS) assessed on 18F-FDG PET/ceCT.","definition_or_measurement_approach":"Per-lesion agreement metrics (positive, negative, overall) between 68Ga-ABS011 HER2 status and treatment response (MR and ETS) on 18F-FDG PET/ceCT."}
• {"endpoint_text":"- 6.Inter-tumor heterogeneity assessment by measuring the proportion of discordance between the total number of lesions and number of overlapping lesions confirmed on 18F-FDG and/or 68Ga-ABS011 PET/CT(VIII) and contrast enhanced CT.","definition_or_measurement_approach":"Measure proportion of discordant lesions between imaging modalities to assess inter-tumor heterogeneity."}
• {"endpoint_text":"- 7.Correlating on a per patient level the proportion of 68Ga-ABS011 PET/CT HER2 positive and negative lesions with the available early treatment outcomes (i.e. MR and ETS).","definition_or_measurement_approach":"Per-patient correlation between proportion of HER2 positive/negative lesions on 68Ga-ABS011 PET/CT and early treatment outcomes (MR, ETS)."}

Belgium

Earliest CTIS Part Ii Submission Date

25-06-2024

Latest Decision Or Authorization Date

28-10-2025

Processing Time Days

490

Number Of Sites

6

Number Of Participants

60

Austria

Earliest CTIS Part Ii Submission Date

22-04-2026

Latest Decision Or Authorization Date

27-04-2026

Processing Time Days

5

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Abscint

Organisation Type

Pharmaceutical company

Country Of Registered Address

Belgium