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Patients with recurrent or metastatic cervical cancer,and will be treated with GLS-010.
Open, uncontrolled, multi-center, phase II study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLS-010 | Experimental | Full-human anti-pd-1 monoclonal antibodies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-010 | Drug | Patients will be given 240mg GLS-010 every treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Based on an independent image assessment board | within 27 Months after patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | meaningful benefit in PFS based on RECIST 1.1 | within 27 Months after patient enrolled |
| DCR | meaningful benefit in DCR based on RECIST 1.1 |
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Inclusion Criteria:
Willingness to participate in the clinical trial; completely understanding and knowing about the study and signing the ICF; willingness and capability to comply with the requirements of the study.
Female aged from 18 to 75 years (margin included).
Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1).
Recurrent or metastatic cervical cancer patients who progress after receiving≥ 1 chemotherapy or are resistant to chemotherapy.
Based on RECIST 1.1, at least one measurable lesions, i.e. an extranodal lesion ≥10 mm in the longest diameter of cross-sectional areas or a lymph node lesion ≥ 15 mm in the shortest diameter of cross-sectional areas in CT or MRI test.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Life expectancy ≥ 12 weeks.
Organ and hematopoietic function as defined below:
Hemoglobin (HGB) ≥ 90 g/L; White blood cell (WBC) ≥ 3 X 109/L; Absolute neutrophil count (ANC) ≥ 1.5 X 109/L; Platelets (PLT) ≥ 100 X 109/L; Total bilirubin≤ 1.5×upper limit of normal (ULN); AST and ALT ≤ 2.5×ULN or, for hepatic dysfunction due to liver metastases, ≤ 5×ULN; Serum creatinine (Cr) ≤ 1.5 X ULN or a creatinine clearance (CrCl) ≥ 50 mL/min; International normalized ratio (INR) or activated partial thromboplastin time (aPTT)≤1.5×ULN;
Female patients of childbearing potential should be willing to birth control after ICF signing, the course of the study, and 5 months after the last dose of study medication.
Patients must agree to provide either an archival tumor tissue sample or fresh biopsy sample for baseline biomarker tissue analyses, including staining for PD-L1. If archival tissue is not available and the patient does not have biopsy-accessible tumor lesions, the patient will be excluded.
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaohua Wu, MD | Contact | 8621-6417 5590 | wu.xh@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiaohua Wu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37875323 | Derived | Xia L, Wang J, Wang C, Zhang Q, Zhu J, Rao Q, Cheng H, Liu Z, Yin Y, Ai X, Gulina K, Zheng H, Luo X, Chang B, Li L, Liu H, Li Y, Lou G, Zhou Q, Zhu Y, Xiao Z, Tong J, Wang K, Chen J, Wang X, Song L, Wei Z, Ye Y, Zhu J, Wu X. Efficacy and safety of zimberelimab (GLS-010) monotherapy in patients with recurrent or metastatic cervical cancer: a multicenter, single-arm, phase II study. Int J Gynecol Cancer. 2023 Dec 4;33(12):1861-1868. doi: 10.1136/ijgc-2023-004705. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
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| within 27 Months after patient enrolled |
| DOR | meaningful benefit in DOR based on RECIST 1.1 | within 27 Months after patient enrolled |
| OS | Overall survival | within 3 years after patient enrolled. |
| TTR | meaningful benefit in TTR based on RECIST 1.1 | within 27 Months after patient enrolled |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |