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Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases

StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Primary completion pushed from Mar 15, 2026 to Feb 28, 2029v2 Show 8 more changesShow less
    • Recruitment opened
    • Study completion pushed from Feb 28, 2029 to Feb 28, 2030
    • Study sites: 1 to 2
    • Start date changed from estimate of Mar 1, 2026 to Feb 6, 2026
    • Secondary endpoints: 6 to 7
    • Collaborators shortened, about 6 words
    • Eligibility criteria shortened, about 4 words
    • Study title expanded, about 1 word
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The combination of local consolidative therapy for oligometastases with systemic therapy offers the potential for clinical cure and significantly prolongs survival in a subset of patients with advanced metastatic disease. However, a considerable proportion of patients still do not benefit from this approach. Becotatug vedotin (MRG003) is an antibody-drug conjugate that carries the payload monomethyl auristatin E (MMAE), a microtubule inhibitor. MMAE has been shown to effectively enhance radiosensitivity in various preclinical tumor models, including head and neck squamous cell carcinoma, liver cancer, gastric cancer, pancreatic cancer, and lung cancer. Furthermore, multiple clinical studies have demonstrated the promising therapeutic potential of vicetuximab in EGFR-positive solid tumors. Based on this background, we plan to conduct a clinical study evaluating the combination of stereotactic body radiotherapy (SBRT) for oligometastases with investigator-selected systemic therapy and Becotatug vedotin (MRG003) in patients with EGFR-positive oligometastatic tumors.
Trial Details
NCT Number NCT07481799
Lead Sponsor Ming-Yuan Chen
Conditions
(from sponsor)		 Oligo-metastatic Cancer
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov