Actively Recruiting
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
Led by ExpreS2ion Biotechnologies · Updated on 2026-04-13
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
Sponsors
E
ExpreS2ion Biotechnologies
Lead Sponsor
G
Gouya Insights
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a new vaccine called ES2B-C001, with or without an adjuvant, in patients with HER2-expressing metastatic breast cancer. This first-in-human, open-label, phase I trial aims to find the maximum tolerated dose and study the immune response and early anti-cancer activity of the treatment in patients who have received prior anticancer therapies. Participants will receive ES2B-C001 vaccine every three weeks for a total of five vaccinations. The vaccine may be given alone or combined with an adjuvant called ISA 51 VD. Different dose levels will be tested in separate patient groups, including 50 µg, 150 µg, and 450 µg doses, with or without the adjuvant, to assess safety and immune effects. Throughout the study, lasting up to 18 weeks, patients will be monitored closely through medical evaluations, laboratory tests, and heart assessments to track safety and immune response. Researchers will observe any side effects, measure immune system activation, and look for early signs of anti-tumor activity. Participants' health and function will be assessed regularly, with particular attention to heart health and any adverse reactions related to the vaccine or adjuvant.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older at screening visit.
- Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic breast cancer with HER2 IHC level 1+, 2+ (FISH negative or positive), or IHC level 3+.
- After 2-3 lines of anticancer therapy.
- Life expectancy of at least 3 months.
- ECOG performance status 0-2.
- Adequate bone marrow, kidney, liver, heart, and lung function without clinically significant abnormalities.
- 12-lead ECG without significant abnormalities including no LBBB, QRS duration >140ms, or prior infarction evidence.
- Recovered from side effects or toxicities related to prior therapy; residual toxicities must be Grade 2 or lower except for alopecia, neuropathy, or lymphoedema.
- If female, non-pregnant, postmenopausal, or practicing reliable contraception.
- If male, sterilized or using reliable contraception.
You will not qualify if you...
- Planned intravenous chemotherapy or checkpoint inhibitors, or prior use within past 1 month with neutropenia; maintenance HER2-directed monoclonal antibodies or antibody drug conjugates allowed.
- Symptomatic CNS metastatic disease requiring high dose steroids within 14 days prior to first ES2B-C001 administration.
- Participation in another clinical trial with investigational drugs or devices within 21 days or 5 half-lives.
- Severe or uncontrolled medical or mental disease unrelated to tumor affecting safety or outcome.
- Previous coronary artery disease or congestive heart failure greater than NYHA II.
- Echocardiography with LVEF below 55%.
- Uncontrolled hypertension.
- Active or suspected autoimmune disease, except controlled thyroid conditions and controlled insulin-dependent diabetes.
- Need for long-term immunosuppression beyond 4 mg dexamethasone.
- Systemic infection requiring intravenous antibiotics within 14 days before dosing.
- Chronic use of antiviral agents except for HIV, HBV, or HCV treatments.
- History of severe hypersensitivity to trial drug components.
- Live or live-attenuated vaccine within 30 days prior to first dose.
- Birthmarks, tattoos, wounds, or skin conditions on injection areas that interfere with reaction assessment.
- Female patients who are pregnant or lactating.
- Any infection that may harm patient safety or study integrity.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 15 weeks
Participants receive ES2B-C001 vaccine with or without an adjuvant every third week for a total of five vaccinations.
5 visits every three weeks (in-person)
Trial Site Locations
Total: 3 locations
1
Medical University of Graz
Graz, Austria
Actively Recruiting
2
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria, 4010
Actively Recruiting
3
Medical University Of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
B
Bent U. Frandsen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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