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.

ExpreS2ion Biotechnologies

Status and phase: Enrolling; Phase 1

Conditions: Breast Cancer; Breast Cancer Metastatic

Treatments: Other: ISA 51 VD; Biological: ES2B-C001

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06746688

2024-516333-12-00 (EU Trial (CTIS) Number)

ES2B-C001-S01

Details and patient eligibility

About

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.

Enrollment: 27 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 3 patient groups

Cohort C1: 50µg ES2B-C001 with [adjuvant]

Experimental group

Treatment:

Biological: ES2B-C001

Other: ISA 51 VD

Cohort C2: 150µg ES2B-C001 with [adjuvant]

Experimental group

Treatment:

Biological: ES2B-C001

Other: ISA 51 VD

Cohort C3: 450µg ES2B-C001 with [adjuvant]

Experimental group

Treatment:

Biological: ES2B-C001

Other: ISA 51 VD