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Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer

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

NCT04886700•CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1\. Age ≥ 18 on the day of signing informed consent and volunteered to participated in this study.
•2\. Histologically documented relapsed or metastatic uterine cervical cancer including squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, a relevant pathological report must also be provided.
•3\. 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.
•4\. Programmed Cell Death Ligand 1 (PD-L1) positive expression defined by Combined Positive Score (CPS) ≥1.
•5\. All the subjects should have at least one measurable lesion in CT or MRI test assessed by RECIST 1.1. A previously irradiated site lesion could only be counted as a target lesion if there was clear sign of progression since the irradiation.
•6\. 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.
•7\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
•8\. Has a predicted survival period ≥ 3 months assessed by investigators.
•9\. Demonstrate adequate organ function as defined below:
•1. Blood routine tests (No blood transfusions were performed, no hematopoietic stimulators were used, and no drugs were used to correct blood cell counts ): Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥75×109/L; Hemoglobin (HGB)≥9 g/dL;
+3 more criteria

Exclusion Criteria

•1\. History of allergic reactions attributed to any monoclonal antibody, and uncontrolled history of allergic asthma.
•2\. 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.
•3\. 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.
•4\. History of primary immunodeficiency.
•5\. 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).
•6\. Has history of Interstitial Lung Disease (Patients caused by radiotherapy are eligible), or non-infectious pneumonitis need for glucocorticoid therapy.
•7\. Have a history of active tuberculosis.
•8\. 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).
•9\. 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.
•10\. Immune-related adverse events of grade 3 or higher（NCI-CTCAE 5.0）after immune therapy.
+10 more criteria

Locations (1)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

Key Dates

Start Date

July 31, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2023

Last Updated

November 22, 2021

Enrollment

104

ESTIMATED participants

Conditions

Uterine Cervical Cancer

Interventions

SG001

DRUG

Contacts

Beibei Zhai

CONTACT

0086-021-60673937 zhaibeibei@mail.ecspc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of the SG001 Injection for Patients With Relapsed or Metastatic Uterine Cervical Cancer

Inclusion Criteria

Exclusion Criteria

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