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Cervical CancerPhase 2CCNCT03972722

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

A Phase 2 study testing GLS-010 in people with Cervical Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with recurrent or metastatic cervical cancer，and will be treated with GLS-010. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
GLS-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
1 siteChina
Study dates
15 May 2019to 15 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
  • 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.
  • A past history of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the investigational product.
  • Pregnancy or lactation.
  • 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].
  • 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.
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  • Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Having received a live vaccine within 4 weeks prior to the first dose of investigational drug.
  • Having received a live anti-tumor vaccine, or anti-tumor treatment with immunostimulation.
  • 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).
  • 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.
  • A known history of human immunodeficiency virus (HIV) infection, or other acquired and congenital immune deficiency diseases.
  • A known history of active tuberculosis within 1 year prior to the first dose of investigational drug.
  • 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.
  • Having undergone allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
  • Having undergone major surgery (with the exception of baseline tumor biopsy), or serious trauma within 4 weeks prior to the first dose of therapy.
  • A history of alcoholism or drug abuse within 1 year.
  • A clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance
  • 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.
  • Subjects not eligible for the study for other reasons, evaluated by the investigator.

Trial locations and contacts

1 site in 1 country.

Xiaohua Wu, MD contact

8621-6417 5590

wu.xh@fudan.edu.cn

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai Municipality

    Xiaohua Wu, MD, 8621-6417 5590, wu.xh@fudan.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Open, Multi-center, Single-arm Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Fully Human Anti-PD-1 Monoclonal Antibody (GLS-010 Injection) in Patients With Recurrent or Metastatic Cervical Cancer

Patients with recurrent or metastatic cervical cancer，and will be treated with GLS-010.

Read the detailed description

Open, uncontrolled, multi-center, phase II study.

Conditions
Cervical Cancer
Being tested
GLS-010
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLS-010Drug

    Also called Full-human anti-pd-1 monoclonal antibodies

    Patients will be given 240mg GLS-010 every treatment.

Study groups in NCT03972722
Study groupRoleWhat they receive
GLS-010ExperimentalFull-human anti-pd-1 monoclonal antibodies
Receives: Drug: GLS-010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Based on an independent image assessment board

    Measured: within 27 Months after patient enrolled

Secondary outcomes (5)

  1. PFS

    meaningful benefit in PFS based on RECIST 1.1

    Measured: within 27 Months after patient enrolled

  2. DCR

    meaningful benefit in DCR based on RECIST 1.1

    Measured: within 27 Months after patient enrolled

  3. DOR

    meaningful benefit in DOR based on RECIST 1.1

    Measured: within 27 Months after patient enrolled

  4. OS

    Overall survival

    Measured: within 3 years after patient enrolled.

  5. TTR

    meaningful benefit in TTR based on RECIST 1.1

    Measured: within 27 Months after patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2019
  2. Study start15 May 2019
  3. Primary completion15 May 2022 (estimated)
  4. Study completion15 May 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
89 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03972722
Sponsor's protocol ID
YH-S001-05
Acronym
CC
Status last verified
May 2019
First submitted
31 May 2019
Last updated
5 Jun 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37875323

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLS-010 in people with Cervical Cancer, run by Guangzhou Gloria Biosciences Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Wu, MD (8621-6417 5590, wu.xh@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: within 27 Months after patient enrolled). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03972722, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.

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