This study is an open, single-arm, multicenter phase II study to investigate the efficacy and safety of SG001 for relapsed or metastatic uterine cervical cancer patients with PD-L1 positive (CPS≧1), and has failed at least first line platinum-based chemotherapy.
Phase II: open, single-arm, multicenter.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
104
Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, China
RECRUITINGObjective response rate (ORR) by RECIST1.1 in relapsed or metastatic uterine cervical cancer evaluated by IRC (Independent Review Committee), confirmation of CR and PR is required in at least 4 weeks after initial documentation.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
ORR (objective response rate) evaluated by investigators.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
DOR (duration of response) evaluated by IRC.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
DCR (disease control rate) evaluated by IRC.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
PFS (free-progression survival) evaluated by IRC.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
OS (overall survival) evaluated by IRC.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
TTR (time to response) evaluated by IRC.
To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.
Time frame: From first dose to the first documented progression of disease, subject withdrawal, lose to follow-up, death, initiating a subsequent cancer therapy, or study completion or termination, whichever occurs earliest, assessed up to 24 months.
Amount, severity, and duration of TEAEs (treatment emergent adverse event) evaluated by NCI-CTCAE V5.0.
To investigate the safety and tolerance profile of SG001 in patients with relapsed or metastatic uterine cervical cancer.
Time frame: From the date of signing Informed Consent Form (ICF) up to 28 days following the last dose of study drug, immune related adverse events will be recorded until 90 days after the last dose.
Population pharmacokinetic parameter IIV (interindividual variability).
The pharmacokinetic profile of SG001.
Time frame: At the end of cycle 7 (every cycle is 14 days).
Population pharmacokinetic parameter exposure-response relationship.
The pharmacokinetic profile of SG001.
Time frame: At the end of cycle 7 (every cycle is 14 days).
Immunogenicity of SG001, such as anti-drug antibody and neutralizing antibody.
To investigate the immune profile of SG001.
Time frame: From the first dose of study drug to the end of treatment visit, up to 24 months.