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.

Last updated: March 13, 2025
Sponsor: ExpreS2ion Biotechnologies
Overall Status: Active - Recruiting

Phase

1

Condition

Breast Cancer

Blood Clots

Stroke

Treatment

ISA 51 VD

ES2B-C001

Clinical Study ID

NCT06746688
ES2B-C001-S01
2024-516333-12-00
  • Ages > 18
  • All Genders

Study 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

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 withoutclinically 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 priortherapy and/or surgery; any residual toxicities and toxicities related to currentanticancer treatment must be ≤ Grade 2, except for alopecia, neuropathy orlymphoedema.

  • If female, non-pregnant, postmenopausal, or practicing reliable contraception.

  • If male, sterilized or using reliable contraception.

Exclusion

Exclusion Criteria:

  • Any planned intravenous chemotherapy regimens, antibody drug conjugates or checkpoint 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 ofHER2-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 firstadministration of ES2B-C001 (with or without adjuvant).

  • Concurrent or recent (within 21 days or 5 half-lives) involvement in any otherclinical trial with an investigational drug, device, or other experimentalintervention.

  • Concomitant severe or uncontrolled underlying medical and/or mental diseaseunrelated to the tumor, which in the opinion of the investigator is likely tocompromise 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 conditionssufficiently controlled on thyroid hormone therapy, and controlled insulin dependentdiabetes.

  • Necessity for long-term immunosuppression (≤ 4 mg dexamethasone may be usedtransiently).

  • Systemic infection requiring intravenous antibiotics within 14 days before dosing.

  • Chronic use of anti-viral agents, except for human immunodeficiency virus (HIV) orhepatitis 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 firstdose of trial treatment. Note: Administration of inactivated or recombinantvaccines/killed vaccines are allowed.

  • Birthmarks, tattoos, wounds, or skin conditions on deltoid region/buttocks that mayobscure 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 orintegrity.

Study Design

Total Participants: 27
Treatment Group(s): 2
Primary Treatment: ISA 51 VD
Phase: 1
Study Start date:
December 17, 2024
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Medical University Of Vienna

    Vienna, 1090
    Austria

    Active - Recruiting

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