A Study in Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive

A Phase 2 study testing GB226 in people with Cervical Cancer, run by Genor Biopharma 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 The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

This study is a multi-center, prospective, open-label, single-arm phase II clinical study to evaluate the efficacy, safety and immunogenicity of GB226 in treatment of recurrent or metastatic cervical cancer patients with PD-L1 positive who failed in platinum-based chemotherapy. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer
What is being tested?: GB226
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 23 May 2019to Jul 2022
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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age ≥18 years old;
2. Understand the steps and contents of the study, and voluntary to sign the written informed consent form;
3. Recurrent or metastatic cervical cancer diagnosed by histology or cytology;
4. Recurrent or metastatic after receiving at least first-line platinum base chemotherapy (≥1 period) (Subjects who progress or recur during or within 6 months after the end of platinum-based new adjuvant or adjuvant chemotherapy are deemed to have received first-line treatment);
5. Subjects must have at least one measurable target lesion (lesion with longest diameter ≥10mm, or lymph node with short diameter ≥15mm) tested by CT or MRI according to the RECIST 1.1 criteria;
6. Expected survival period ≥3 months;

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7. ECOG score 0-1 point;
8. Subjects shall provide sufficient formalin fixed paraffin embedded (FFPE) specimens or sections prepared from tumor archived tissues or fresh tissues that meet the test criteria, and are willing to perform biopsy of tumor tissues for test of PD-L1 if needed. The archived tissue shall be a representative tumor specimen within three years, or unstained serial sections (not less than 4) of the newly cut FFPE tumor tissue within six months, and the above-mentioned specimens related pathology reports shall also be provided. Fresh tissue specimens can be obtained by resection, core needle biopsy, excision, stamping or forceps biopsy (more than 100 tumor cells must be guaranteed); samples are not accepted for fine needle puncture and liquid based cytology test (TCT) (namely, the samples lack of complete tissue structure thus to only provide cell suspension and/or cell smear); decalcified bone metastatic tumor samples are not accepted. For core-needle biopsy specimens, at least 3 single paraffin embedded specimens shall be submitted for evaluation. For patients with PD-L1 negative in initially archived tumor tissue samples, biopsy can be performed during screening with the patients' consent to provide fresh tissue prepared paraffin blocks or sections for retest of PD-L1 status, and the qualification of this study is met if any kind of tumor tissue samples have positive results;
9. The values of laboratory tests performed during screening shall meet the following criteria:
Blood routine test (No blood transfusion within 14 days before test, no use of G-CSF, no use of drug correction);
Hemoglobin (HGB) ≥90 g/L;
Absolute neutrophil count (ANC) ≥1.5×109/L;
Blood platelet (PLT) ≥100×109/L；
Biochemical test
Total bilirubin (TBIL) ≤1.5× Upper limit of normal (ULN) (Gilbert syndrome allowance ≤5×ULN);
Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN (if liver metastasis exists, ALT and AST ≤5×ULN);
Serum creatinine (Cr) ≤1.5×ULN or endogenous creatinine clearance rate ≥50mL/min (Cockcroft-Gault formula);
10. Thyroid function index: Thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are in normal range; Subjects could be enrolled if FT3/FT4 in the normal range,and TSH without the normal range;
11. Women who are not pregnant within 7 days before administration of study drug; women in child-bearing period shall agree to use medically approved effective contraception throughout the whole study period and within 6 months after completion of study;
12. Subjects can be followed up on schedule, able to communicate well with the investigator, and able to complete the study in accordance with the requirements of this study.

Who cannot join

1. Patient with other previous malignancies (except the cured skin basal cell carcinoma or squamous cell carcinoma) shall not participate in this study unless she experiences a "complete response" for at least 5 years before enrollment, and it is estimated that no other anti-tumor therapy will be required during the whole study;
2. Active central nervous system (CNS) metastasis, including symptomatic brain metastasis or meningeal metastasis or spinal cord compression, etc.; asymptomatic brain metastasis can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no postoperative neurological symptoms or signs, no need for treatment with glucocorticoid, anticonvulsant drugs or mannitol);
3. Experienced systemic chemotherapy, radial/extensive radiotherapy, targeted therapy, anti-tumor biotherapy (e.g. tumor vaccine, cytokine or growth factor, etc.) within 28 days before administration of study drug, or experienced local palliative radiotherapy within 14 days;
4. Less than 14 days before the study was conducted with major surgery or severe trauma(Subjects could be enrolled ,except for skin or percutaneous biopsy with local anesthesia ,and recovered within 7 days);
5. Received corticosteroids (prednisone > 10 mg/day or equivalent dose) or other immunosuppressive drugs within 14 days before administration of study drug;
6. Have active, known history of autoimmune disease, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, etc. other than type I diabetes mellitus, hypothyroidism controlled only by hormone replacement therapy, skin diseases (e.g. vitiligo) requiring no systemic treatment and controlled celiac disease;

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7. Complications requiring the treatment with immunosuppressive drugs, or complications requiring systemic treatment at the dose with immunosuppressive effects (prednisone > 10mg/day or equivalent dose to similar drug); in the absence of active autoimmune disease, inhaling or local administration of steroids and prednisone at dose > 10mg/day or equivalent dose to similar drug are allowed;
8. Uncontrolled hypertension (systolic pressure >140 mmHg and/or diastolic pressure > 90 mmHg) or pulmonary hypertension or unstable angina pectoris; underwent myocardial infarction, bypass or stent surgery within 6 months before administration; have a history of grade 3-4 chronic heart failure that meets the criteria of New York Heart Association (NYHA); Valvular heart disease with clinical significance; severe arrhythmia requiring treatment, including QTc interval ≥ 470 ms (calculate by Fridericia formula); left ventricular ejection fraction (LVEF) < 50%; Cerebral vascular accident (CVA) or transient ischemic attach (TIA) within 6 months before administration, etc.;
9. Complicated with other serious medical disease, including but not limited to uncontrolled diabetes mellitus, active gastrointestinal ulcers, active hemorrhage, etc.;
10. Subjects suffering from active infections that require systemic treatment;
11. Patients with previous or present infection with active tuberculosis;
12. Have the previous history of interstitial pulmonary disease;
13. Uncontrollable symptomatic dropsy of serous cavity, such as ascites, pleural effusion or pericardial effusion;
14. Human immunodeficiency virus antibody (HIV-Ab) and Treponema pallidum positive; hepatitis C antibody (HCV-Ab) positive, and hepatitis C virus RNA quantification > the upper limit of normal of test unit; hepatitis B surface antigen (HBsAg) positive, and hepatitis B virus test value > the upper limit of normal of test unit;
15. Adverse events caused by previous treatment have not recovered to grade 1 or below (CTCAE5.0) (except the grade 2 neurotoxicity caused by alopecia and chemotherapeutics);
16. Have been treated with anti PD-1 antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4 antibody (or any other antibodies acting on T cell co-stimulation or checkpoint pathway);
17. Used live vaccine or attenuated vaccine within 28 days before administration of study drug;
18. Used other study drugs or study devices within 30 days before administration of study drug;
19. Patients with a history of drug addiction or drug abuse upon inquiry;
20. Patients with previous definite neurological or mental disorders, such as epilepsy, dementia, poor compliance;
21.Lactating women who do not agree to stop breastfeeding ;
22. Known allergy to recombinant human PD-1 monoclonal antibody or any of its excipients; known history of allergic disease or severe allergic constitution;
23. Patients who are not suitable for participating in this study due to other various reasons upon investigator's opinions.

Trial locations and contacts

1 site in 1 country.

Shawn Yu, master contact

86-010-65260820

shawn.yu@genorbio.com

China1 site, 1 recruiting

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Lingying Wu, 0086-010-67781331,china, wulingying@csco.org.cn
Wu Lingying, Medical PhD
Recruiting

Other trials in China

About this study

Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy

Conditions: Cervical Cancer
Being tested: GB226
Keywords: recurrent Metastatic Cervical Cancer, platinum
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.

GB226Biological
Also called Geptanolimab
GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.

Study groups in NCT03808857
Study group	Role	What they receive
GB226	Experimental	Geptanolimab Injection,3mg/kg once per 2 weeks Receives: Biological: GB226

What is being measured

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

Objective response rate, ORR
To evaluate the efficacy of GB226 as defined by objective response rate, in patients with recurrent or metastatic cervical cancer.
Measured: 2 years

Secondary outcomes (5)

Disease control rate,DCR
To evaluate the efficacy of GB226 as defined by overall response rate, in patients with recurrent or metastatic cervical cancer.
Measured: 2 years
Time to response, TTR
To evaluate the efficacy of GB226 as defined by time to response in patients with recurrent or metastatic cervical cancer.
Measured: 2 years
Duration of response, DOR
To evaluate the duration of response (DOR) of GB242 in patients with recurrent or metastatic cervical cancer.
Measured: 2 years
Progression-free survival, PFS
To evaluate the efficacy of GB226 as defined by progression-free survival, in patients with recurrent or metastatic cervical cancer.
Measured: 2 years
Overall survival, OS
To evaluate the duration from the first administration to death because of any reason in patients with recurrent or metastatic cervical cancer.
Measured: 2 years

Timeline

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

23 May 2019Jul 2022

First posted18 Jan 2019
Study start23 May 2019
Primary completionDec 2021 (estimated)
Study completionJul 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03808857
Sponsor's protocol ID: Gxplore-008
Status last verified: Mar 2021
First submitted: 27 Dec 2018
Last updated: 3 Mar 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Shawn Yu, master

86-010-65260820

shawn.yu@genorbio.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of GB226 in Treatment of Recurrent or Metastatic Cervical Cancer Patients With PD-L1 Positive Who Failed in Platinum-based Chemotherapy
ClinicalTrials.gov ID: NCT03808857
Acronym / sponsor ID: Gxplore-008
Conditions: Cervical Cancer
Keywords: recurrent Metastatic Cervical Cancer, platinum
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 80 participants (estimated)
Lead sponsor: Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 23 May 2019 (actual)
Primary completion: Dec 2021 (estimated)
Study completion: Jul 2022 (estimated)
First posted: 18 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
GB226	Experimental	Biological: GB226Geptanolimab Injection,3mg/kg once per 2 weeks

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

1. Age ≥18 years old;
2. Understand the steps and contents of the study, and voluntary to sign the written informed consent form;
3. Recurrent or metastatic cervical cancer diagnosed by histology or cytology;
4. Recurrent or metastatic after receiving at least first-line platinum base chemotherapy (≥1 period) (Subjects who progress or recur during or within 6 months after the end of platinum-based new adjuvant or adjuvant chemotherapy are deemed to have received first-line treatment);
5. Subjects must have at least one measurable target lesion (lesion with longest diameter ≥10mm, or lymph node with short diameter ≥15mm) tested by CT or MRI according to the RECIST 1.1 criteria;

Key exclusion criteria (23 listed)

1. Patient with other previous malignancies (except the cured skin basal cell carcinoma or squamous cell carcinoma) shall not participate in this study unless she experiences a "complete response" for at least 5 years before enrollment, and it is estimated that no other anti-tumor therapy will be required during the whole study;
2. Active central nervous system (CNS) metastasis, including symptomatic brain metastasis or meningeal metastasis or spinal cord compression, etc.; asymptomatic brain metastasis can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no postoperative neurological symptoms or signs, no need for treatment with glucocorticoid, anticonvulsant drugs or mannitol);
3. Experienced systemic chemotherapy, radial/extensive radiotherapy, targeted therapy, anti-tumor biotherapy (e.g. tumor vaccine, cytokine or growth factor, etc.) within 28 days before administration of study drug, or experienced local palliative radiotherapy within 14 days;
4. Less than 14 days before the study was conducted with major surgery or severe trauma(Subjects could be enrolled ,except for skin or percutaneous biopsy with local anesthesia ,and recovered within 7 days);
5. Received corticosteroids (prednisone > 10 mg/day or equivalent dose) or other immunosuppressive drugs within 14 days before administration of study drug;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GB226Also: GeptanolimabGB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.	Biological	GB226

Primary outcome

Objective response rate, ORR
Time frame: 2 years
To evaluate the efficacy of GB226 as defined by objective response rate, in patients with recurrent or metastatic cervical cancer.

5 secondary outcomes

Disease control rate,DCR
Time frame: 2 years
Time to response, TTR
Time frame: 2 years
Duration of response, DOR
Time frame: 2 years
Progression-free survival, PFS
Time frame: 2 years
Overall survival, OS
Time frame: 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.

Related trials for Cervical Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shawn Yu, master contact

86-010-65260820

shawn.yu@genorbio.com

Lingying Wu, Doctor principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB226 in people with Cervical Cancer, run by Genor Biopharma 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 20 inclusion and 23 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 3 Mar 2021. 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 Shawn Yu, master (86-010-65260820, shawn.yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate, ORR (time frame: 2 years). 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 NCT03808857.

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 3 Mar 2021.