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.
Age: 18 to 75 years (inclusive), male or female.
Patients with histologically or cytologically confirmed recurrent or metastatic solid tumors who are not amenable to curative surgery.
Oligometastatic lesions detected on imaging (biopsy of metastatic tissue is preferred but not mandatory). The total number of metastatic lesions must be <=5.
The primary tumor has been treated radically and is controlled.
History of severe hypersensitivity to any component of monoclonal antibodies.
The investigator's choice of systemic therapy regimen contains taxanes (or other microtubule inhibitors) .
Severe infection within 4 weeks prior to the start of study treatment; or active infection of CTCAE Grade>=2 requiring systemic antibiotic treatment within 2 weeks prior to the first dose.
The interval between the last dose of oral fluorouracil or small molecule targeted drugs and the first dose of study treatment is > 2 weeks or 5 half-lives (whichever is shorter);
Parallel
Becotatug Vedotin
DrugBecotatug vedotin was administered intravenously at a dose of 2.0 mg/kg every 3 weeks (Q3W).
SBRT
RadiationAll oligometastatic lesions will be treated with SBRT with curative intent. Radiation doses are determined based on published clinical studies
Systemic Therapy/Standard of Care
DrugSystemic therapy /Standard of Care will be determined at the investigator's discretion, in accordance with clinical guidelines and individual patient characteristics.
Progression-free Survival (PFS)
Defined as time from randomization to loco-regional or distant metastasis relapse or death from any cause, whichever occurred first.
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Objective Response Rate (ORR)
Defined as the proportion of patients whose tumors shrink to complete response (CR) or partial response (PR) and remain for a certain period of time according to RECIST 1.1.
Disease Control Rate (DCR)
Defined as the proportion of patients whose tumors shrink to complete response (CR), partial response (PR) or stable disease (SD) and remain for a certain period of time according to RECIST 1.1.
Duration of Response (DoR)
Defined as the time from the first documented Complete Response (CR) or Partial Response (PR) to the first documented disease progression (PD) or death from any cause in patients with an objective response
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Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
