Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06746688

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.

Led by ExpreS2ion Biotechnologies · Updated on 2026-04-13

40

Participants Needed

3

Research Sites

78 weeks

Total Duration

On this page

Sponsors

E

ExpreS2ion Biotechnologies

Lead Sponsor

G

Gouya Insights

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged  18 years at screening visit.
  • Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic breast cancer, with HER2 IHC level 1+, 2+ (either FISH negative or positive), or IHC level 3+, after undergoing 2-3 lines of anticancer therapy.
  • Life expectancy of at least 3 months.
  • ECOG performance status 0-2.
  • Adequate bone marrow, kidney, liver, heart, and lung function without clinically significant abnormalities as judged by the investigator.
  • 12-lead ECG without clinically significant abnormalities and no left bundle branch block, QRS duration >140 ms, or evidence of prior infarction.
  • Recovery from side effects, adverse reactions, or adverse events due to prior therapy and/or surgery; any residual toxicities 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.
Not Eligible

You will not qualify if you...

  • Planned intravenous chemotherapy regimens or checkpoint inhibitors, or previous therapy with those agents during the past 1 month with neutropenia. Maintenance therapy with stable HER2-directed monoclonal antibodies or antibody drug conjugates for metastatic breast cancer is allowed.
  • Symptomatic CNS metastatic disease requiring high dose steroids (above 10 mg prednisone or equivalent) within 14 days before first dose.
  • Participation in another clinical trial with investigational drugs, devices, or experimental interventions within 21 days or 5 half-lives.
  • Severe or uncontrolled medical or mental disease unrelated to the tumor likely to compromise safety or study outcome.
  • Previous coronary artery disease or congestive heart failure greater than NYHA class II.
  • Echocardiography showing left ventricular ejection fraction below 55%.
  • Uncontrolled hypertension.
  • Active, known, or suspected autoimmune disease except well-controlled thyroid conditions and controlled insulin-dependent diabetes.
  • Need for long-term immunosuppression (up to 4 mg dexamethasone allowed transiently).
  • Systemic infection requiring intravenous antibiotics within 14 days before dosing.
  • Chronic use of antiviral agents except for HIV or hepatitis B or C treatments.
  • History of severe allergic reactions to any trial drug components.
  • Receipt of live or live-attenuated vaccine within 30 days before first dose. Inactivated or recombinant vaccines are allowed.
  • Birthmarks, tattoos, wounds, or skin conditions on deltoid region or buttocks that may interfere with injection site assessment.
  • Female patients who are pregnant or breastfeeding.
  • Any infection, including SARS-CoV-2, that may endanger patient safety or integrity during the trial.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Medical University of Graz

Graz, Austria

Actively Recruiting

2

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Austria, 4010

Actively Recruiting

3

Medical University Of Vienna

Vienna, Austria, 1090

Actively Recruiting

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Research Team

B

Bent U. Frandsen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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