RecruitingPhase 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 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

Sponsor

ExpreS2ion Biotechnologies

Enrollment

27 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Breast Cancer Metastatic

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

Patients aged ≥18 years at screening visit.
Diagnosis of HER2-positive metastatic or locally advanced inoperable breast cancer (MBC).
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.
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.

Exclusion Criteria16

Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are not neutropenic. For MBC maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) at the discretion of the treating physician is allowed.
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.