Overview

Study of GLS-010 Injection in Patients With Recurrent or Metastatic Cervical Cancer

Status:
Recruiting
Trial end date:
2023-05-15
Target enrollment:
0
Participant gender:
Female
Summary
Patients with recurrent or metastatic cervical cancer,and will be treated with GLS-010.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guangzhou Gloria Biosciences Co., Ltd.
Treatments:
Antibodies
Antibodies, Monoclonal
Antineoplastic Agents, Immunological
Immunoglobulins
Criteria
Inclusion Criteria:

1. 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.

2. Female aged from 18 to 75 years (margin included).

3. Cervical cancer patients with histologically confirmed PD-L1 positive (CPS ≥ 1).

4. Recurrent or metastatic cervical cancer patients who progress after receiving≥ 1
chemotherapy or are resistant to chemotherapy.

5. 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.

6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

7. Life expectancy ≥ 12 weeks.

8. 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;

9. 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.

10. 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:

1. Prior therapy with an anti-PD1, anti-PDL1, anti-PDL2, anti-CD137 or anti-CTLA-4 agent
(including Ipilimumab or any other drug specifically targeting T-cell co-stimulation
or checkpoint pathways).

2. Prior anti-tumor therapy,(including chemotherapy, targeted small molecule therapy ,
radiotherapy, immunotherapy, mAb therapy) , or treatment with investigational products
having not been launched onto the market in China in other clinical trials within 4
weeks prior to the first dose.

3. A past history of allergic reactions attributed to any macromolecular protein
preparation/monoclonal antibody, or any other composition of the investigational
product.

4. Pregnancy or lactation.

5. Patients with any autoimmune disease and received systemic therapy within 2 years
(i.e. corticosteroids or immunosuppressive medications) [i.e.,but not limited to,
uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism,
hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and
chemotherapy can be included), patients with vitiligo or asthma CR in Childhood, not
requiring any intervention in adulthood are permitted to enroll; patients with asthma
requiring a bronchiectasis intervention are not permitted to enroll].

6. Subjects that requires systemic corticosteroids (dose equivalent to or above 10 mg
prednisone daily) or other immunosuppressive medications within 14 days prior to
enrollment or for the course of the study.

7. Patients with known active central nervous system (CNS) metastases and/or
carcinomatous meningitis.

8. Having received a live vaccine within 4 weeks prior to the first dose of
investigational drug.

9. Having received a live anti-tumor vaccine, or anti-tumor treatment with
immunostimulation.

10. Serious medical illness, such as severe infections, uncontrollable diabetes mellitus,
cardiovascular diseases (i.e., grade 3 or 4 congestive heart failure (New York Heart
Association (NYHA)), ≥ grade 2 heart block, myocardial infarction, uncontrolled
arrhythmias, or unstable angina within 6 months prior to screening, and cerebral
infarction within 3 months prior to screening) or lung diseases (i.e. interstitial
pneumonia, obstructive pulmonary disease and symptomatic bronchospasm).

11. Patients with positive HBsAg and/or positive HBcAb with positive hepatitis B virus
DNA> 103 copies/mL, or positive hepatitis C virus antibody; or positive syphilis.

12. A known history of human immunodeficiency virus (HIV) infection, or other acquired and
congenital immune deficiency diseases.

13. A known history of active tuberculosis within 1 year prior to the first dose of
investigational drug.

14. Presence of other malignant cancers within 5 years prior to enrollment. Patients with
cured carcinoma in situ and cured skin basal cell carcinoma or cutaneous squamous cell
carcinoma are eligible.

15. Having undergone allogeneic hematopoietic stem cell transplantation or solid organ
transplantation.

16. Having undergone major surgery (with the exception of baseline tumor biopsy), or
serious trauma within 4 weeks prior to the first dose of therapy.

17. A history of alcoholism or drug abuse within 1 year.

18. A clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor
compliance

19. Patients with other severe, acute or chronic disease that might increase risk of study
drug use and participation, or laboratory abnormality that might confound the results
of the trial.

20. Subjects not eligible for the study for other reasons, evaluated by the investigator.