Alveolar Soft Part Sarcoma Clinical Trial
Official title:
An Open-label, Single-arm, Phase II Clinical Study of Anti-PD-1 Antibody GB226 in Treatment of Relapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma (ASPS)
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.
Patients received Geptanolimab 3mg/kg via intraveneous infusion every 2 weeks until disease progression, death, unacceptable toxicity, withdrawal of consent or end the the study (i.e. a maximum treatment duration of one years of the last subject, termination of treatment, consent withdrawal, lost to follow-up or death, whichever occurs first). During the treatment period, subjects were evaluated for safety (once every 2 weeks) and efficacy (once every 6 weeks)，If clinical symptoms suggestive of PD occur, an external visit should be arranged to complete the imaging evaluation and confirmation. Geptanolimab treatment was permitted to continue beyond the first RECIST-defined progressive disease (PD), if clinical benefit was noted and the toxicity was acceptable. No dose modification was allowed, but dose discontinuation was permitted for up to six weeks for adverse events. Safety was monitored until 30 days and/or 90 days (without initiation of another anticancer treatment) after the last dose of the study drug, for all patients received at least one dose of treatment. At the end of the treatment, for the subjects who have not yet developed PD and have not started the subsequent anti-tumor treatment, the efficacy evaluation will continue every 6 weeks (± 7 days) in the first 3 months, and every 12 weeks thereafter, until the end of the study or withdrawal of informed consent or occurrence of PD, initiation of a new anti-tumor treatment, death or lost to follow-up. All subjects who had received GB226 treatment at least once were required to have survival follow-up visits, which were planned every 3 months (± 14 days) after the safety follow-up / disease progression follow-up visit. The end of the study was defined as the death, loss of visit, withdrawal of informed consent and completion of the final study visit of the last subject, and the end of treatment of the last subject for one year or the early end of the study, whichever occurs first. ;
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