NCT07481799

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Ming-Yuan Chen · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Oligo-metastatic Cancer

Interventions

Type	Name	Description
DRUG	Becotatug Vedotin	Becotatug vedotin was administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).
RADIATION	SBRT	All oligometastatic lesions will be treated with SBRT with curative intent. Radiation doses are determined based on published clinical studies
DRUG	Systemic 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.

Timeline

• Start date: 2026-02-06
• Primary completion: 2029-02-28
• Completion: 2030-02-28
• First posted: 2026-03-19
• Last updated: 2026-04-02

Locations

2 sites across 1 country: China