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.

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 criteria:
inclusion criteria: * patients aged ≥18 years at screening visit. * diagnosis of her2-positive metastatic or locally advanced inoperable breast cancer (mbc). * life expectancy of at least 6 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. exclusion criteria: * any planned intravenous chemotherapy regimens, antibody drug conjugates or check point inhibitors, or previous therapy with those agents during the past 2 months, or 5 half-lives whichever is longer. for mbc maintenance therapy with a stable dose of her2-directed mabs 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.

Keywords: breast cancer mbc metastatic breast cancer