The trial is a first-in-human, phase I, open-label, dose-escalating trial to assess the safety and tolerability of ES2B-C001 combined with or without \[adjuvant\], in patients with human epidermal growth factor receptor 2 (HER2) expressing metastatic breast cancer.
Patients aged ≥18 years at screening visit.
Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic BC, with HER2 IHC level 1+, 2+ (either FISH negative or positive), or IHC level 3+, after undergoing 2-3 lines of anticancer therapy.
Life expectancy of at least 3 months.
ECOG performance status 0-2.
Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are neutropenic. Maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) for metastatic BC is allowed at the discretion of the treating physician.
Symptomatic CNS metastatic disease requiring treatment with high dose steroids (i.e., above 10 mg of prednisone or equivalent) within 14 days prior to first administration of ES2B-C001 (with or without adjuvant).
Concurrent or recent (within 21 days or 5 half-lives) involvement in any other clinical trial with an investigational drug, device, or other experimental intervention.
Concomitant severe or uncontrolled underlying medical and/or mental disease unrelated to the tumor, which in the opinion of the investigator is likely to compromise patient safety and affect the trial's outcome.
Sequential
ES2B-C001
Biological/VaccineVaccine; Administration with or without \[adjuvant\] every third week for a total of five vaccinations.
ISA 51 VD
Other interventionAdjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations.
To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].
* Nature and frequency of dose-limiting toxicities (DLTs). * Incidence, nature and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. * Incidence, nature and severity of injection site reactions according to FDA Guidance on Toxicity Grading Scales in Vaccine Trials (FDA, 2007).
To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].
Immunogenicity as humoral immune response: Total anti-HER2 Immunoglobulin G (IgG) and IgG lambda titers in sera by enzyme-linked immunosorbent assay (ELISA).
To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].
Optionally, characterization of anti-HER2 immunoglobulins in selected sera, including isotyping (e.g. IgM, IgG and IgG subclasses IgG1-4, IgD, IgE, IgA) and analysis of HER2 epitope recognition profiles.
To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
Percentage of patients with measurable disease at baseline achieving Complete Remission (CR) or Partial Response (PR) according to RECIST 1.1 as assessed by the investigator during routine follow up.
To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
Percentage of patients with Disease Control Rate (DCR) according to RECIST 1.1 as assessed by the investigator during routine follow up.
To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
Progression free survival (PFS) in patients with Stable Disease (SD), or PR, at the time of first dosing of ES2B-C001 alone or in combination with \[adjuvant\] according to RECIST 1.1.
To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
Overall survival (OS)
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ExpreS2ion Biotechnologies
Lead sponsor
Gouya Insights
Collaborator
VelaLabs
Collaborator
KKS MedUni Vienna
Collaborator
