A Single-arm, Open-label, Multicenter, Phase II Study for Evaluation of Efficacy and Safety of the SG001 Injection for Patients With PD-L1-positive Relapsed or Metastatic Uterine Cervical Cancer

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 site in 1 country104 target enrollmentJuly 31, 2021

ConditionsUterine Cervical Cancer

InterventionsSG001

DrugsSG001

Overview

Phase: Phase 2
Intervention: SG001
Conditions: Uterine Cervical Cancer
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 104
Locations: 1
Primary Endpoint: Objective 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.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Phase II: open, single-arm, multicenter.

Registry

clinicaltrials.gov

Start Date

July 31, 2021

End Date

December 31, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥ 18 on the day of signing informed consent and volunteered to participated in this study.
•Histologically documented relapsed or metastatic uterine cervical cancer including squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, a relevant pathological report must also be provided.
•Relapsed or metastatic uterine cervical cancer patient who has failed at least first line platinum-based chemotherapy, which means having disease progression during or following at least first line platinum based chemotherapy or for which platinum based chemotherapy is not tolerated, having disease progression within 6 months of or during neoadjuvant or adjuvant treatment with platinum based chemotherapy can also be accepted.
•Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥
•All the subjects should have at least one measurable lesion in CT or MRI test assessed by RECIST 1.
•A previously irradiated site lesion could only be counted as a target lesion if there was clear sign of progression since the irradiation.
•If subjects have received anti-tumor therapies before, the toxicity severity must decrease to ≤ Grade1 evaluated by NCI-CTCAE 5.0, except for residual alopecia or fatigue.
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
•Has a predicted survival period ≥ 3 months assessed by investigators.
•Demonstrate adequate organ function as defined below:

Exclusion Criteria

•History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma.
•Patients with other types of malignant tumours that have progressed or require treatment within 5 years prior to the screening, but well-treated skin basal cell carcinoma, skin squamous cell carcinoma, or superficial bladder cancer, and having cured carcinoma in situ, e.g. breast carcinoma in situ, can be accepted.
•Patients with any active autoimmune disease, but subjects with following diseases are allowed for further screening: subjects with well-controlled type I diabetes, well-controlled hypothyroidism with hormone replacement therapy, skin diseases (such as vitiligo, psoriasis, or hair loss) without systemic treatment, or who are not expected to relapse without external triggers.
•History of primary immunodeficiency.
•Patients with serious cardiovascular diseases, such as grade 2 or above heart failure based on the NYHA (New York Heart Association) Class guidelines, previous myocardial infarction within 3 months, poorly controlled arrhythmias or unstable angina pectoris, previous arterial or venous thrombosis events within 3 months (e.g. transient ischemic attack, cerebral hemorrhage, cerebral infarction, deep vein thrombosis and pulmonary embolism).
•Has history of Interstitial Lung Disease (Patients caused by radiotherapy are eligible), or non-infectious pneumonitis need for glucocorticoid therapy.
•Have a history of active tuberculosis.
•Subjects with untreated or treated but still symptomatic central nervous system metastases (except for residual signs or symptoms related to CNS treatment, those with stable or improved neurological symptoms at least 2 weeks prior to screening can be included).
•Prior therapy with any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways including anti-PD-1, anti-PD-L1, anti CTLA-4, OX40 agonist, and anti-CD137, etc.
•Immune-related adverse events of grade 3 or higher（NCI-CTCAE 5.0）after immune therapy.

Arms & Interventions

SG001

Recombinant Human Anti-PD-1 Monoclonal Antibody

Intervention: SG001

Outcomes

Primary Outcomes

Objective 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.

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.

To investigate the efficacy of SG001 in relapsed or metastatic uterine cervical cancer.

Secondary Outcomes

Immunogenicity of SG001, such as anti-drug antibody and neutralizing antibody.(From the first dose of study drug to the end of treatment visit, up to 24 months.)
PFS (free-progression survival) evaluated by IRC.(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.(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.(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).(At the end of cycle 7 (every cycle is 14 days).)
Population pharmacokinetic parameter exposure-response relationship.(At the end of cycle 7 (every cycle is 14 days).)
ORR (objective response rate) evaluated by investigators.(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.(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.(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.(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.)