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;
Single group
Becotatug Vedotin
DrugBecotatug Vedotin will be given at a dose of 2.0 mg/kg via intravenous infusion on Day 1 of every 3 week cycle (Q3W).
Pucotenlimab
DrugPucotenlimab will be administered intravenously at 3.0 mg/kg (or as a flat dose of 200 mg) also on Day 1 of each Q3W cycle.
Objective Response Rate (ORR)
Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1).
Overall Survival(OS)
Time from start of treatment to death due to any cause.
Adverse Events (AEs)
Number of participants with adverse effects of treatment. Frequency and severity of adverse effects of treatment as assessed by NCI CTCAE.
Progression Free Survival(PFS)
The time from the beginning of the patient's treatment to the disease progression or death for any reason.Based on RECIST criteria v1.1.
Radiological Progression-Free Survival(rPFS)
Progression-free survival (PFS) based on radiographic assessment by the investigator using RECIST version 1.1
EGFR Expression Level and Efficacy Correlation
Exploratory analysis evaluating the association between baseline EGFR expression levels (H-score or IHC) and ORR/PFS.
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Tianjin Medical University Second Hospital
Lead sponsor
Lepu Biopharma Co., Ltd.
Collaborator
