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.

Launched by EXPRES2ION BIOTECHNOLOGIES · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called ES2B-C001, with or without another substance called Montanide, for patients with a specific type of breast cancer known as HER2-positive metastatic breast cancer. This is the first time this treatment is being tested in humans, and the main goal is to see how safe it is and how well patients can tolerate it. The trial is currently looking for participants who are at least 18 years old, have been diagnosed with this type of breast cancer, and have a life expectancy of at least six months.

To participate, individuals should be in generally good health, with normal functioning of their organs, and should not have recently received other specific cancer treatments. They should also not have serious underlying health issues that could interfere with the trial. If eligible, participants can expect to receive the treatment and will be closely monitored for any side effects or reactions. It's important to note that while this is a trial for a new treatment, it is designed to help improve future options for patients with HER2-positive metastatic breast cancer.

Gender

ALL

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.