Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)
- Conditions
- Alveolar Soft Part Sarcoma
- Interventions
- Biological: GB226
- Registration Number
- NCT03623581
- Lead Sponsor
- Genor Biopharma Co., Ltd.
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description GB226 3mg/kg every 2 weeks GB226 Geptanolimab Injection, 3mg/kg every 2 weeks
- Primary Outcome Measures
Name Time Method Objective Response Rate, ORR up to 52 weeks To evaluate the efficacy of GB226 as defined by objective response rate in patients with ASPS.
- Secondary Outcome Measures
Name Time Method Disease Control Rate，DCR up to 52 weeks To evaluate the disease Control Rate (DCR) of GB226 in patients with ASPS.
iPFS up to 52 weeks iPFS
iORR up to 52 weeks iORR
iDOR up to 52 weeks iDOR
The concentration of Antidrug antibody up to 52 weeks To evaluate the immunogenicity in patients with ASPS.
Duration of response, DOR up to 52 weeks To evaluate the duration of response (DOR) of GB226 in patients with ASPS.
Incidence and severity of immune-related adverse events up to 52 weeks Incidence and severity of immune-related adverse events
iDCR up to 52 weeks iDCR
Progression-free survival, PFS up to 52 weeks To evaluate the efficacy of GB226 as defined by progression-free survival in patients with ASPS.
Incidence and severity of serious adverse events up to 52 weeks Incidence and severity of serious adverse events
Overall survival, OS up to 52 weeks To evaluate the duration from the first administration to death because of any reason in patients with ASPS.
Incidence and severity of adverse events up to 52 weeks Incidence and severity of adverse events
Trial Locations
- Locations (1)
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China