Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)
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|ClinicalTrials.gov Identifier: NCT03623581|
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : May 27, 2020
|Condition or disease||Intervention/treatment||Phase|
|Alveolar Soft Part Sarcoma||Biological: GB226||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||September 6, 2018|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 30, 2020|
Experimental: GB226 3mg/kg every 2 weeks
Geptanolimab Injection, 3mg/kg every 2 weeks
3mg/kg treat every 2 weeks
- Objective Response Rate, ORR [ Time Frame: up to 52 weeks ]To evaluate the efficacy of GB226 as defined by objective response rate in patients with ASPS.
- Progression-free survival, PFS [ Time Frame: up to 52 weeks ]To evaluate the efficacy of GB226 as defined by progression-free survival in patients with ASPS.
- Duration of response, DOR [ Time Frame: up to 52 weeks ]To evaluate the duration of response (DOR) of GB226 in patients with ASPS.
- Disease Control Rate，DCR [ Time Frame: up to 52 weeks ]To evaluate the disease Control Rate (DCR) of GB226 in patients with ASPS.
- Overall survival, OS [ Time Frame: 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 [ Time Frame: up to 52 weeks ]Incidence and severity of adverse events
- Incidence and severity of immune-related adverse events [ Time Frame: up to 52 weeks ]Incidence and severity of immune-related adverse events
- Incidence and severity of serious adverse events [ Time Frame: up to 52 weeks ]Incidence and severity of serious adverse events
- iORR [ Time Frame: up to 52 weeks ]iORR
- iDCR [ Time Frame: up to 52 weeks ]iDCR
- iPFS [ Time Frame: up to 52 weeks ]iPFS
- iDOR [ Time Frame: up to 52 weeks ]iDOR
- The concentration of Antidrug antibody [ Time Frame: up to 52 weeks ]To evaluate the immunogenicity in patients with ASPS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623581
|Contact: Shawn Yu, Masterfirstname.lastname@example.org|
|Cancer Hospital Chinese Academy of Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100021|
|Contact: Yuankai Shi, Doctor|
|Principal Investigator: Yuankai Shi, Doctor|
|Principal Investigator:||Yuankai Shi, Doctor||Study Principal Investigator Cancer Hospital Chinese Academy of Medical Sciences|