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RECRUITING
NCT07481799
PHASE3

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

Sponsor: Ming-Yuan Chen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2026-02-06

Completion Date

2030-02-28

Last Updated

2026-04-02

Healthy Volunteers

No

Interventions

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.

Locations (2)

The Fifth Affiliated Hospital,Sun Yat-sen University

Zhuhai, Guangdong, China

The Fifth Affiliated Hospital,Sun Yat-sen University

Zhuhai, Guangdong, China