Henan Cancer Hospital

A multicenter, single-arm, open-label, phase Ib/II study conducted in China evaluated JMT103 in patients with unresectable or surgically-challenging giant cell tumor of bone (GCTB). The study, approved by ethics committees and registered at ClinicalTrials.gov (NCT04255576), involved 24 centers and administered JMT103 subcutaneously at 2 mg/kg every four weeks. Primary endpoints included histopathological or radiological objective tumor response (OTR), with secondary endpoints covering overall response rate (ORR), disease control rate (DCR), time to progression (TTP), and safety. Statistical analyses were performed using SAS software, with a sample size of 125 patients to ensure a 95% confidence interval for OTR.

EVER-132-002 study, compliant with Helsinki and ICH GCP guidelines, was approved by national authorities and ethics committees. It enrolled HR+HER2- metastatic or locally recurrent BC patients from China, Korea, and Taiwan, requiring prior chemotherapy and measurable disease. Patients were randomized 1:1 to receive SG or chemotherapy, with PFS as the primary endpoint. Secondary endpoints included OS, ORR, DoR, CBR, safety, and QoL. Assessments involved tumor measurements, safety evaluations, and QoL questionnaires. Statistical analysis included sample size calculation, HR estimation, and safety summaries. The study design details are available in the Nature Portfolio Reporting Summary.