Clinical trial 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.
Official title: A First-In-Human Phase I, Open-Label, Dose-Escalating Trial to Assess the Safety, Tolerability and Immunogenicity/Preliminary Antitumor Activity of ES2B-C001 With or Without [Adjuvant] in HER2 Expressing Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Breast Cancer Metastatic
Keywords: breast cancer
MBC
metastatic breast cancer
Lead sponsor: ExpreS2ion Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: Gouya Insights
name: VelaLabs
name: KKS MedUni Vienna
First posted: 2024-12-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: open-label, dose-escalating
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].
timeFrame: From enrolment to the end of study at week 18
measure: To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].
timeFrame: From enrolment to the end of study at week 18
measure: To determine the safety, tolerability, maximum tolerated dose (MTD) for ES2B-C001 alone or in combination with [adjuvant].
timeFrame: From enrolment to the end of study at week 18
Secondary outcomes:
measure: To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].
timeFrame: From enrolment to the end of study at week 18
measure: To investigate the immunogenicity of ES2B-C001 alone or in combination with [adjuvant].
timeFrame: From enrolment to the end of study at week 18
Other outcomes:
measure: To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
timeFrame: From enrolment to the end of study at week 18
measure: To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
timeFrame: From enrolment to the end of study at week 18
measure: To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
timeFrame: From enrolment to the end of study at week 18
measure: To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
timeFrame: From enrolment to the end of study at week 18
measure: To determine the preliminary antitumor activity of ES2B-C001 alone or in combination with [adjuvant] observed.
timeFrame: From enrolment to the end of study at week 18
Locations:
city: Vienna
country: Austria
facility: Medical University Of Vienna
Study officials:
affiliation: ExpreS2ion Biotechnologies
name: Thomas K. Jorgensen
role: STUDY_DIRECTOR
References: