RecruitingPhase 3NCT07481799

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

Phase 3 Clinical Study on the Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases


Sponsor

Ming-Yuan Chen

Enrollment

200 participants

Start Date

Feb 6, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Becotatug Vedotin, SBRT, and others for people with oligo-metastatic cancer. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBecotatug Vedotin

Becotatug vedotin was administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).

RADIATIONSBRT

All oligometastatic lesions will be treated with SBRT with curative intent. Radiation doses are determined based on published clinical studies

DRUGSystemic Therapy/Standard of Care

Systemic therapy /Standard of Care will be determined at the investigator's discretion, in accordance with clinical guidelines and individual patient characteristics.


Locations(2)

The Fifth Affiliated Hospital,Sun Yat-sen University

Zhuhai, Guangdong, China

The Fifth Affiliated Hospital,Sun Yat-sen University

Zhuhai, Guangdong, China

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NCT07481799