Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(… (NCT03623581) | Clinical Trial Compass
UnknownPhase 2
Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)
China35 participantsStarted 2018-09-06
Plain-language summary
This study is a single-arm, phase 2 trial of Geptanolimab in patients with initially unresectable, recurrent or metastatic ASPS. The study aims to study the activity of Geptanolimab assessed per RECIST 1.1 and iRECIST criteria, and safety profile.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Sign the informed consent form;
✓. Aged 18\~75 years old, males or females;
✓. ECOG score of 0-1;
✓. The expected survival is 3 months or longer;
✓. Histologically or cytologically confirmed relapsed or metastatic or unresectable alveolar soft part sarcoma (ASPS);
✓. There is at least one measurable lesion, which is defined as lesion accurately measured in one dimension (RECIST1.1: the longest diameter of non-lymph node lesions≥10mm, the shortest diameter of lymph node lesions ≥15mm);
✓. The previous treatment is completed ≥4 weeks or ≥5 half-lives of the previous therapeutic agents (whichever is shorter) before administration (at least 1 week interval between previous treatment and study enrollment); washout with nitrosoureas, mitomycin C, RANKL inhibitor for at least 6 weeks; previous radiotherapy must be performed at least 4 weeks ago; the previous monoclonal antibody treatment must be performed at least 6 weeks ago;
✓. If the patients received more than 350mg/m2 cumulative dose of adriamycin, echocardiography should be performed and left ventricular ejection fraction (LVEF) ≥50%;
Exclusion criteria
✕. Subjects who received anti-PD-1 or anti-PD-L1 monoclonal antibody or targeted drugs of relevant pathways;
✕. Subjects who are known to be allergic to PD-1 monoclonal antibody or any of its excipients, or subjects who are known to have medical history of allergic diseases or serious allergic constitution;
✕. Subjects who have other malignant tumor diseases other than tumor treated in this study, excluding cured malignant tumors which did not relapse within 3 years before enrollment, completely resected basal cell and squamous cell skin cancer, any type of in situ carcinoma which is completely resected;
✕. Active central nervous system (CNS) metastasis (regardless of whether any treatment is received), including symptomatic brain metastasis or meningeal metastasis or spinal cord compression etc.; excluding asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);