Breast CancerPhase 1NCT06746688
A First-in-human, Clinical Trial Assessing the Safety of ES2B-C001-S01 With or Without [Adjuvant] in Patients With HER2-expressing Metastatic Breast Cancer.
A Phase 1 study testing ES2B-C001 and ISA 51 VD in people with Breast Cancer and Breast Cancer Metastatic, run by ExpreS2ion Biotechnologies at 3 sites in Austria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Metastatic
- What is being tested?
- ES2B-C001 and ISA 51 VD
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesAustria
- Study dates
- 3 Jun 2025to Sep 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator.
- 12-lead ECG without clinically significant abnormalities and no LBBB, QRS duration >140 ms, or evidence of prior infarction.
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- Recovered from side effects, adverse reactions, or adverse events due to prior therapy and/or surgery; any residual toxicities and toxicities related to current anticancer treatment must be ≤ Grade 2, except for alopecia, neuropathy or lymphoedema.
- If female, non-pregnant, postmenopausal, or practicing reliable contraception.
- If male, sterilized or using reliable contraception.
Who cannot join
- 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.
- Previous documented coronary artery disease or congestive heart failure (>NYHA II).
- Echocardiography with LVEF <50%.
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- Uncontrolled hypertension.
- Active, known, or suspected autoimmune disease, except thyroid conditions sufficiently controlled on thyroid hormone therapy, and controlled insulin dependent diabetes.
- Necessity for long-term immunosuppression (≤ 4 mg dexamethasone may be used transiently).
- Systemic infection requiring intravenous antibiotics within 14 days before dosing.
- Chronic use of anti-viral agents, except for human immunodeficiency virus (HIV) or hepatitis B or C virus (HBV, HCV) treatments.
- History of severe hypersensitivity reactions to any of the trial drug components.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Note: Administration of inactivated or recombinant vaccines/killed vaccines are allowed.
- Birthmarks, tattoos, wounds, or skin conditions on deltoid region/buttocks that may obscure the assessment of injection site reactions.
- Female patients who are pregnant, or lactating.
- Any infection (including SARS-CoV-2), that in the opinion of the investigator would, upon inclusion in the trial, lead to potentially harming patients' safety or integrity.
Trial locations and contacts
3 sites in 1 country.
Austria3 sites
Medical University of Graz
Graz
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010
Medical University Of Vienna
Vienna, 1090
About this study
Official title: A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2-expressing Metastatic Breast Cancer
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.
- Conditions
- Breast Cancer, Breast Cancer Metastatic
- Being tested
- ES2B-C001, ISA 51 VD
- Keywords
- breast cancer, MBC, metastatic breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES2B-C001Biological
Vaccine; Administration with or without [adjuvant] every third week for a total of five vaccinations.
ISA 51 VDOther
Adjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| Cohort C1: 50µg ES2B-C001 with [adjuvant] | Experimental | Not described Receives: Biological: ES2B-C001; Other: ISA 51 VD |
| Cohort C2: 150µg ES2B-C001 with [adjuvant] | Experimental | Not described Receives: Biological: ES2B-C001; Other: ISA 51 VD |
| Cohort C3: 450µg ES2B-C001 with or without [adjuvant] | Experimental | Not described Receives: Biological: ES2B-C001; Other: ISA 51 VD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrolment to the end of study at week 18
Secondary outcomes (1)
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).
Measured: From enrolment to the end of study at week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start3 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- open-label, dose-escalating
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ExpreS2ion Biotechnologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gouya Insights, VelaLabs, KKS MedUni Vienna
- Responsible party
- Sponsor
- Investigators
- Thomas K. Jorgensen, Study director, ExpreS2ion Biotechnologies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746688
- Sponsor's protocol ID
- ES2B-C001-S01
- Other IDs
- 2024-516333-12-00
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Within the study de-identified patient data will be shared with * the operational study team, sponsor, auditor and for reporting of safety events to the regulatory agencies and EC * Data Monitoring Committees/ or other independent committees during the study * At the end - data listings are part of the Appendices of the CSR which will be shared to regulatory agencies and EC
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2-expressing Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT06746688
- Acronym / sponsor ID
- ES2B-C001-S01
- Conditions
- Breast Cancer, Breast Cancer Metastatic
- Keywords
- breast cancer, MBC, metastatic breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ExpreS2ion BiotechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- Gouya Insights, VelaLabs, KKS MedUni Vienna
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- open-label, dose-escalating
| Arm | Type | Receives |
|---|---|---|
| Cohort C1: 50µg ES2B-C001 with [adjuvant] | Experimental | Biological: ES2B-C001, Other: ISA 51 VD |
| Cohort C2: 150µg ES2B-C001 with [adjuvant] | Experimental | Biological: ES2B-C001, Other: ISA 51 VD |
| Cohort C3: 450µg ES2B-C001 with or without [adjuvant] | Experimental | Biological: ES2B-C001, Other: ISA 51 VD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator.
Key exclusion criteria (16 listed)
- 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.
- Previous documented coronary artery disease or congestive heart failure (>NYHA II).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES2B-C001Vaccine; Administration with or without [adjuvant] every third week for a total of five vaccinations. | Biological | Cohort C1: 50µg ES2B-C001 with [adjuvant], Cohort C2: 150µg ES2B-C001 with [adjuvant], Cohort C3: 450µg ES2B-C001 with or without [adjuvant] |
| ISA 51 VDAdjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations. | Other | Cohort C1: 50µg ES2B-C001 with [adjuvant], Cohort C2: 150µg ES2B-C001 with [adjuvant], Cohort C3: 450µg ES2B-C001 with or without [adjuvant] |
Primary outcome
To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].
Time frame: From enrolment to the end of study at week 18
* 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).
1 secondary outcome
To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].
Time frame: From enrolment to the end of study at week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. Within the study de-identified patient data will be shared with * the operational study team, sponsor, auditor and for reporting of safety events to the regulatory agencies and EC * Data Monitoring Committees/ or other independent committees during the study * At the end - data listings are part of the Appendices of the CSR which will be shared to regulatory agencies and EC
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas K. Jorgensen study director
ExpreS2ion Biotechnologies
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ES2B-C001 and ISA 51 VD in people with Breast Cancer and Breast Cancer Metastatic, run by ExpreS2ion Biotechnologies at 3 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant]. (time frame: From enrolment to the end of study at week 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.