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Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Start date changed from estimate of Feb 2026 to Apr 16, 2026 · Site details revisedv9 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2026 to Apr 16, 2026
    • Site details revised
  2. Minor Interventions: ABY-025 Loading Dose (Drug), [68Ga]Ga-ABY-025 (Drug) to [68Ga]Ga-ABY-025 (Drug) Study description shortened, about 4 wordsv8 Show 1 more changeShow less
    • Study description shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Notable Start date: Nov 2025 to Feb 2026v7
  4. Notable Primary endpoint revisedv6 See this version in full on ClinicalTrials.gov ↗
  5. Notable Primary endpoint revised Start date: Oct 2025 to Nov 2025 · Eligibility criteria expanded, about 18 wordsv5 Show 2 more changesShow less
    • Start date: Oct 2025 to Nov 2025
    • Eligibility criteria expanded, about 18 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Notable Start date: May 2025 to Oct 2025v4
  2. Notable Start date: Feb 2025 to May 2025v3
  3. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
5,213 trials monitored
See 271 trials at risk
1,201 trials monitored
See 59 trials at risk
and 1 more disease
The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.
Trial Details
NCT Number NCT06828588
Lead Sponsor Vanderbilt-Ingram Cancer Center
Conditions Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov