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.

NCT06746688 | Recruiting Phase 1 DMC

• 2 other identifiers: ES2B-C001-S012024-516333-12-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer; Breast Cancer Metastatic

Keywords

breast cancer; MBC; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].

  * Nature and frequency of dose-limiting toxicities (DLTs). * Incidence, nature and severity of AEs graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. * Incidence, nature and severity of injection site reactions according to FDA Guidance on Toxicity Grading Scales in Vaccine Trials (FDA, 2007).

  From enrolment to the end of study at week 18

Secondary Outcomes (2)

• To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].

  From enrolment to the end of study at week 18

• To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].

  From enrolment to the end of study at week 18

Other Outcomes (4)

• To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.

  From enrolment to the end of study at week 18

• To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.

  From enrolment to the end of study at week 18

• To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.

  From enrolment to the end of study at week 18

Study Arms (3)

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

EXPERIMENTAL

Biological: ES2B-C001; Other: ISA 51 VD

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

EXPERIMENTAL

Biological: ES2B-C001; Other: ISA 51 VD

Cohort C3: 450µg ES2B-C001 with or without [adjuvant]

EXPERIMENTAL

Biological: ES2B-C001; Other: ISA 51 VD

Interventions

ES2B-C001 BIOLOGICAL

Vaccine; Administration with or without \[adjuvant\] every third week for a total of five vaccinations.

Cohort C1: 50µg ES2B-C001 with [adjuvant]; Cohort C2: 150µg ES2B-C001 with [adjuvant]; Cohort C3: 450µg ES2B-C001 with or without [adjuvant]

ISA 51 VD OTHER

Adjuvant; Administration together with ES2B-C001 every third week for a total of five vaccinations.

Cohort C1: 50µg ES2B-C001 with [adjuvant]; Cohort C2: 150µg ES2B-C001 with [adjuvant]; Cohort C3: 450µg ES2B-C001 with or without [adjuvant]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥18 years at screening visit.
• Diagnosis of HER2-expressing locally advanced, unresectable, or metastatic BC, 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.
• Patients have adequate bone marrow, kidney, liver, heart, and lung function without clinically significant laboratory parameters as judged by the investigator.
• 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.

You may not qualify if:

• Any planned intravenous chemotherapy regimens or check point inhibitors, or previous therapy with those agents during the past 1 month and the patients are neutropenic. Maintenance therapy with a stable dose of HER2-directed mAbs or treatment with antibody drug conjugates (ADCs) for metastatic BC is allowed at the discretion of the treating physician.
• 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.

Sponsors & Collaborators

• ExpreS2ion Biotechnologies: lead
• Gouya Insights: collaborator
• VelaLabs: collaborator
• KKS MedUni Vienna: collaborator

Study Sites (3)

Medical University of Graz

Graz, Austria

RECRUITING

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, 4010, Austria

RECRUITING

Medical University Of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Thomas K. Jorgensen

  ExpreS2ion Biotechnologies

  STUDY DIRECTOR

Central Study Contacts

Bent U. Frandsen

CONTACT

+4522221019; info@expres2ionbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: open-label, dose-escalating

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 24, 2024
• Study Start: June 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

AU (3)