This phase II trial evaluates the combination of Becotatug Vedotin (MRG003), an EGFR-targeting ADC, and Pucotenlimab (HX008), a PD-1 inhibitor, in patients with high EGFR expressing advanced refractory solid tumors. The study is designed to assess clinical efficacy and safety, building on a strong synergistic rationale and promising early-phase data.
Age≥18 years at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 7 days prior to the first dose. ECOG 2 is allowable if it is solely attributable to tumor progression, as judged by the investigator.
Life expectancy≥ 12 weeks.
Histologically or cytologically confirmed locally advanced or metastatic solid tumors that have failed standard therapy (progressive disease or intolerance to prior treatment), or for whom standard therapy is currently not applicable or unavailable. There is no limit on the number of prior lines of therapy.
Presence of uncontrolled serious medical conditions, including severe cardiac disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.
History of allergy or hypersensitivity to any component of monoclonal antibody-based agents, or known allergic constitution.
New York Heart Association (NYHA) Class ≥ II heart failure, or left ventricular ejection fraction (LVEF) < 50% on echocardiography;
Unstable angina;
Tianjin Medical University Second Hospital
Lead sponsor
Lepu Biopharma Co., Ltd.
Collaborator