Actively Recruiting
Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases
Led by Ming-Yuan Chen · Updated on 2026-04-02
200
Participants Needed
2
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of SBRT Combined With Becotatug Vedotin (MRG003) in EGFR-Positive Metastatic Tumor Patients With Oligometastases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Histologically or cytologically confirmed recurrent or metastatic solid tumors not curable by surgery
- Up to 5 oligometastatic lesions detected on imaging
- Primary tumor has been treated and is controlled
- Able to provide tumor tissue samples for EGFR testing from primary or metastatic sites
- All metastatic lesions deemed suitable for SBRT by a multidisciplinary team
- If prior local therapy was done on metastatic lesions, controlled lesions are eligible without further SBRT
- Uncontrolled metastatic lesions previously treated with surgery and amenable to SBRT are eligible
- Maximum brain metastasis size 3 cm or less
- Maximum size of extra-cranial metastases 5 cm or less (up to 6 cm for certain bone metastases if safe)
- ECOG performance status of 0 or 1
- Life expectancy of at least 6 months
You will not qualify if you...
- Severe allergy to any component of monoclonal antibodies
- Use of systemic therapy containing taxanes or other microtubule inhibitors
- Severe infection within 4 weeks before treatment or active infection requiring antibiotics within 2 weeks
- Anti-tumor therapy within 4 weeks before treatment, with specific exceptions for certain drugs or therapies
- Use of strong CYP3A4, CYP2D6, or P-gp inhibitors or inducers within 5 half-lives before treatment
- Prior treatment with EGFR antibody-drug conjugates or ADCs containing microtubule inhibitors
- History or signs of interstitial lung disease or severe lung conditions affecting function
- Spinal cord compression or tumor less than 3 mm from spinal cord
- Moderate to severe heart disease or arrhythmia
- Brain metastases needing surgical decompression
- Presence of malignant effusions or other active cancers
- Dementia or seizure disorders
- Chronic use of immunosuppressive medication or high-dose corticosteroids recently
- Active or recent tuberculosis treatment
- Active or history of autoimmune diseases except fully resolved childhood asthma or vitiligo
- HIV positive or active hepatitis infections
- Recent vaccination with anti-infective vaccines within 4 weeks
- Positive pregnancy test or breastfeeding
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China, 519099
Not Yet Recruiting
2
The Fifth Affiliated Hospital,Sun Yat-sen University
Zhuhai, Guangdong, China, 519099
Actively Recruiting
Research Team
M
Mingyuan Chen
CONTACT
X
Xiaoting Cai
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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