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.

StatusActive, Not Recruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment closed, study ongoing Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to Sep 2028
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 2 to 1
    • Site details revised at 3 of 3 sites
  2. Primary and study completion dates: Mar 2026 to Dec 2026v7 Show 5 more changesShow less
    • Enrollment target: 27 to 40
    • Study sites: 1 to 3
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study title shortened, about 1 word
  3. Primary endpoints: 3 to 1
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 2 of 2 entries
    v6
  4. Start date: Dec 17, 2024 to Jun 3, 2025v5
  5. Primary endpoints revised (3)
    • Secondary endpoints revised (2)
    • Site contact updated
    • Study title shortened, about 17 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Dec 17, 2024
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06746688
Lead Sponsor ExpreS2ion Biotechnologies
Collaborators: Gouya Insights, VelaLabs, KKS MedUni Vienna
Conditions
(from sponsor)		 Breast Cancer, Breast Cancer Metastatic
Related terms Breast Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov