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.
Recruiting now · Phase 1
Conditions studied: Breast Cancer, Breast Cancer Metastatic
In brief
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.
Key facts
- Study ID
- NCT06746688
- Run by
- ExpreS2ion Biotechnologies
- People needed
- 40
- Starts
- 2025-06-03
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 >140ms, or evidence of prior infarction.
- 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.
You may not qualify if…
- 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 <55%.
- 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.
Where it is running
- Medical University of Graz — Graz, Austria (enrolling)
- Ordensklinikum Linz GmbH Barmherzige Schwestern — Linz, Austria (enrolling)
- Medical University Of Vienna — Vienna, Austria (enrolling)
Full record on ClinicalTrials.gov
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