Evaluating the Diagnostic Performance of Human Epidermal Growth Factor Receptor 2 (HER2) targeted Positron Emission Tomography and Computed Tomography (PET/CT) with 68Ga-ABS011 in metastatic Breast Cancer (mBC) and other metastatic solid carcinomas.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Abscint

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Trial duration

3 Sep 2024 → ongoing

Decision date (initial)

2026-04-27

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-511419-22-00

ClinicalTrials.gov

NCT06369831

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis, Others

To evaluate the diagnostic performance of 68Ga-ABS011 PET/CT compared to the standard of care IHC (and ISH) HER2 status test (all indications).

Secondary objectives 6

1. 2. To confirm the safety of 68Ga-ABS011 (all indications).
2. 3. To evaluate whether whole body mapping of HER2 expression with 68Ga-ABS011 can drive changes in the treatment management of the mBC patients (mBC only)..
3. 4. To evaluate reliability of whole body 68Ga-ABS011 PET/CT compared to established tools to diagnose HER2 expression (i.e. IHC(IV) and ISH(V)) (all indications).
4. 5. To evaluate reliability of whole body 68Ga-ABS011 PET/CT compared to HER2-targeted treatment response (i.e. tumor shrinkage and metabolic response) (mBC only).
5. 6. To evaluate whether whole body 68Ga-ABS011 PET/CT can determine HER2 expression heterogeneity (mBC only).
6. 7. Evaluate whether intra-patient heterogeneity influences prognosis of mBC (all indications).

Conditions and MedDRA coding

Hormone receptor positive/HER2 negative, triple-negative or HER2 positive metastatic Breast Cancer (mBC) and other metastatic solid carcinomas

Study design 1 period

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. 1. Adult (≥ 18 years at the time of informed consent signature) male or female patient
2. 2. Patient with confirmed de novo or pre-treated mBC (multiple previous treatment lines in metastatic setting are allowed).
3. 3. Patients 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).
4. 4. Patient 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).
5. 5. Patient willing to undergo at least one tumor biopsy.
6. 6. Male 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.
7. 7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2.
8. 8. Ability and willingness of the research participant to provide written informed consent.
9. Same 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 14

1. 1. Primary (non-metastatic) breast cancer.
2. 10. Patients 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).
3. 11. Patients 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).
4. 12. Patients who cannot undergo PET/CT scanning (including but not limited to body size and claustrophobia).
5. 13. Any 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).
6. 2. Patient not willing to undergo at least one tumor biopsy.
7. 3. 18F-FDG PET/ceCT completed before screening and patient not willing to repeat this assessment.
8. 4. Metastatic 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.
9. 5. Brain and liver metastases are the sole sites of metastatic disease.
10. 6. Life expectancy lower than 3 months.
11. 7. Pregnancy or breastfeeding.
12. 8. Inadequate organ function, suggested by clinically relevant abnormal laboratory results: a. Significantly impaired renal function defined as estimated GFR <30 ml/min/1.73m2. b. Total bilirubin ≤1.5 x Upper Limit of Normal (ULN) (unless the patient has documented Gilbert's syndrome). c. Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or Alanine aminotransferase (ALT)/ serum glutamic pyruvic transaminase (SGPT) >5.0 x ULN.
13. 9. Patients with a known hypersensitivity to any of the IMP components or packaging.
14. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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: - Positive % diagnostic agreement - Negative % diagnostic agreement - Overall % diagnostic agreement

Secondary endpoints 11

1. 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).
2. 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.
3. 4.1.Positive predictive value of 68Ga-ABS011 using IHC(IV) and ISH(V) as a reference: a. Proportion of lesions with a HER2 positive 68Ga-ABS011 status and a confirmed HER2 IHC non-0 status. b. Proportion of lesions with a HER2 positive 68Ga-ABS011 status and a positive ISH status.
4. 4.2.Negative predictive value of 68Ga-ABS011 of 68Ga-ABS011 using IHC(IV) and ISH(V) and as a reference: a. Proportion of lesions with a negative 68Ga-ABS011 status and a HER2 IHC 0 status. b. Proportion of lesions with a negative 68Ga-ABS011 status and a negative ISH status.
5. 4.3.Positive and negative likelihood ratio of 68Ga-ABS011 PET/CT using IHC(IV) and ISH(V) as a reference.
6. 5.1.Positive predictive value of 68Ga-ABS011 using 18F-FDG PET/ceCT(VIII) as a reference: a. The 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. The 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).
7. 5.2.Negative predictive value of 68Ga-ABS011 of 68Ga-ABS011 using 18F-FDG PET/ceCT(VIII) as a reference. a. Proportion 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. Proportion 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).
8. 5.3.Positive and negative likelihood ratio of 68Ga-ABS011 PET/CT using 18F-FDG PET/ceCT(VIII) as a reference.
9. 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.
10. 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.
11. 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).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Abscint

Sponsor organisation

Abscint

Address

Boulevard De Patience Et Beajonc 3 Boite 23

City

Liege

Postcode

4000

Country

Belgium

Scientific contact point

Organisation

Abscint

Contact name

Karine Clauwaert

Public contact point

Organisation

Abscint

Contact name

Karine Clauwaert

Locations

2 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 26 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications