Advanced Solid TumorPhase 1GB226NCT03374007

Phase I Clinical Trial in Chinese Patients of Advanced and (or) Recurrent Solid Tumor/Lymphoma

A Phase 1 study testing Geptanolimab Injection 1mg/kg, Geptanolimab Injection 3mg/kg and Geptanolimab Injection 10mg/kg in people with Advanced Solid Tumor and Recurrent Solid Tumor, run by Genor Biopharma Co., Ltd. at 2 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Search all trials

Trial summary

With open, single/ multiple dosing and dose escalation, phase I clinical trial scheme to evaluate safety, tolerance and pharmacokinetic properties of Genolimzumab injection in Chinese patients of advanced and (or) recurrent solid tumor/lymphoma Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Advanced Solid Tumor, Recurrent Solid Tumor, Lymphoma
What is being tested?: Geptanolimab Injection 1mg/kg, Geptanolimab Injection 3mg/kg and Geptanolimab Injection 10mg/kg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 2 sitesChina
Study dates: 19 Oct 2017to Aug 2022
Phase: Phase 1
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Age: 18-65. Unisex.
2. Understand trial procedure and content and sign informed consent voluntarily;
3. Patients of advanced (phase Ⅲb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent solid tumor (including melanoma, NSCLC, renal cell carcinoma, head \& neck cancer, esophagus cancer, liver cancer, bladder cancer, spongioblastoma) or lymphoma (classical hodgkin lymphoma and (or) peripheral T-cell lymphoma, natural killer (NK)-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. There is no effective standard treatment now.
4. Agree to provide recorded tumor tissue sample or fresh tissue sample.
5. Eastern Cooperative Oncology Group (ECOG): 0-1;
6. Expected life ≥ 3 months;

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7. With at least one measurable and evaluable tumor (solid tumor is subject to criteria for evaluating efficacy of Immune-Related Response Criteria (irRC)/RECIST and lymphoma is subject to criteria/revised criteria of international working group);
8. Chemotherapy of the whole body is completed at least 4 weeks before inclusion.
9. Radiotherapy of the whole body and partial palliative radiotherapy are completed at least 4 weeks before inclusion.
10. Corticosteroids (prednisone>10mg/d or equivalent) has been stopped at least 2 weeks before inclusion.
11. Autotransplantation is completed at least 3 months before inclusion.
12. Major surgeries with the need of general anesthesia are completed at least 4 weeks. Surgeries with the need of local anesthesia/epidural anesthesia are completed at least 2 weeks and the subjects have recovered. Skin biopsies with the need of local anesthesia are completed at least 1 hour before inclusion.
13. Previous tumor biotherapy (tumor vaccine, cell factor or growth factor for the purpose of tumor control) is completed at least 4 weeks before inclusion;
14. Without severe haematological, cardiopulmonary, liver and kidney diseases except protopathic. For patients of solid tumor, hemoglobin≥9g/dl, neutrophile granulocyte≥1.5×109/L, blood platelet≥100×1012/L. For patients of hematologic tumor, hemoglobin≥8g/dl, neutrophile granulocyte≥1.0×109/L, blood platelet≥80×1012/L.
15. Serum creatinine≤1.5xUpper Limit Of Normal (ULN) or creatinine clearance rate≥50mL/min and urine protein<2+ in test paper of urine. For patients with urine protein great than or equal to 2+ in test paper of urine, urine shall be collected in 24 hours and urine protein must less than or be equal to 1g.
etc.

Who cannot join

1. Active central nervous system metastasis; If central nervous system (CNS) metastasis of patients can be treated and their symptoms of nervous system can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) for 2 weeks when they are included, they can participate in the research. Cranial CT or MRI scanning shall be made for the patients 30 days before inclusion.
2. Meningeal metastases or meningeal infiltration of tumors;
3. Patients with other malignant tumors (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) shall not participate in the research, unless he/she has been fully relieved at least 2 years without the need of other treatment or other treatment is not needed during the research.
4. With active, known or suspected autoimmune disease.
5. With previous usage of PD-1 antibody, PD-L1 antibody, PD-L2 antibody or cytotoxic T-lymphocyte-associated antigen-4 immunoglobulin (CTLA-4) antibody for treatment (or other antibody for co-stimulation or check point assess of T cells)
6.With severe internal medicine diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, active peptic ulcer, active bleeding.

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7. With active infection.
8. With active tuberculosis infection; with active tuberculosis infection in the past.
9. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and treponema pallidum antibody (TP-Ab). Positive subjects of HBsAg may not be excluded from patients of liver cancer.
10. Complication with the need of immunosuppressive drug or complication with the need of corticosteroids for whole or partial body in the dosage of immunosuppressive action.
etc.

Trial locations and contacts

2 sites in 1 country.

Shawn Yu, Master contact

86-010-65260820

shawn.yu@genorbio.com

China2 sites, 2 recruiting

Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Yuankai Shi, Doctor
Yuankai Shi, Doctor
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Qingyuan Zhang, Doctor
Qingyuan Zhang, Doctor
Recruiting

Other trials in China

About this study

Official title: With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection

Read the detailed description

Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: GB226) is joint developed by Genor Biopharma Co. Ltd and Crown Bioscience,Inc., it is the reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO) cells express system expressed in a immunoglobulin G4 (IgG4) kappa type single resistance to predominate. GB226 had the different new amino acid sequence and molecular structure compared with two marketed PD-1 monoclonal antibody injection and got the approval of China Food and Drug Administration (CFDA) for clinical trial.Pharmaceutical research indicated GB226 cell strain had security source, production process is stable, quality can control, preparation stability, has good compatibility with packaging materials, it has the condition of industrialization, can prepare investigational medicinal product with safety, effective, and controlled quality for clinical research.Pharmacodynamics study show the targets and mechanisms of GB226 is clear, tumor suppression effect is obvious.Toxicology studies show this product in high doses with low toxic, and the toxic is reversible, the most common toxicity is specific to the drug action mechanism.

Conditions: Advanced Solid Tumor, Recurrent Solid Tumor, Lymphoma, Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Being tested: Geptanolimab Injection 1mg/kg, Geptanolimab Injection 3mg/kg, Geptanolimab Injection 10mg/kg, Geptanolimab Injection 1mg/kg, q2w*6, Geptanolimab Injection 3mg/kg, q2w*6
Medical subject headings: Lymphoma, Hodgkin Disease

What participants receive

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

Geptanolimab Injection 1mg/kgBiological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
single-dose:1mg/kg
Geptanolimab Injection 3mg/kgBiological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
single-dose: 3mg/kg
Geptanolimab Injection 10mg/kgBiological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
single-dose:10mg/kg
Geptanolimab Injection 1mg/kg, q2w*6Biological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
multiple dosing: 1mg/kg, q2w*6
Geptanolimab Injection 3mg/kg, q2w*6Biological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
multiple dosing: 3mg/kg, q2w*6
Geptanolimab Injection 10mg/kg, , q2w*6Biological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
multiple dosing: 10mg/kg, , q2w*6
Geptanolimab Injection 280mg, q3wBiological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
multiple dosing: 280mg, q3w
Geptanolimab Injection 3mg/kg, q2wBiological
Also called Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injection
multiple dosing: 3mg/kg, q2w

Study groups in NCT03374007
Study group	Role	What they receive
GB226 1mg/kg single-dose	Experimental	Geptanolimab, 1mg/kg, i.v., single-dose Receives: Biological: Geptanolimab Injection 1mg/kg
GB226 3 mg/kg single-dose	Experimental	Geptanolimab, 3mg/kg, i.v., single-dose Receives: Biological: Geptanolimab Injection 3mg/kg
GB226 10mg/kg single-dose	Experimental	Geptanolimab 10mg/kg, i.v., single-dose Receives: Biological: Geptanolimab Injection 10mg/kg
GB226 1mg/kg multiple dosing, every 2 weeks	Experimental	Geptanolimab, 1mg/kg, i.v., q2w6 Receives: Biological: Geptanolimab Injection 1mg/kg, q2w6
GB226 3mg/kg multiple dosing,every 2 weeks	Experimental	Geptanolimab, 3mg/kg, i.v., q2w6 Receives: Biological: Geptanolimab Injection 3mg/kg, q2w6
GB226 10mg/kg multiple dosing, every 2 weeks	Experimental	Geptanolimab,10mg/kg, i.v., q2w6 Receives: Biological: Geptanolimab Injection 10mg/kg, , q2w6
GB226 280mg multiple dosing	Experimental	Geptanolimab, 280mg, i.v., q3w Receives: Biological: Geptanolimab Injection 280mg, q3w
GB226 3mg/kg multiple dosing	Experimental	Geptanolimab, 3mg/kg, i.v., q2w Receives: Biological: Geptanolimab Injection 3mg/kg, q2w

What is being measured

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

adverse event
adverse event
Measured: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Serious Adverse Event
Serious Adverse Event
Measured: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Dose limiting Toxicity, DLT
Dose limiting Toxicity, DLT
Measured: Day 1 to Day 28 after first dose
Maximum Tolerated Dose, MTD
Maximum Tolerated Dose, MTD
Measured: Day 1 to Day 28 after first dose

Secondary outcomes (11)

AUC 0-t
AUC 0-t
Measured: up to 12 weeks
C max
C max
Measured: up to 12 weeks
AUC 0-∞
AUC 0-∞
Measured: up to 12 weeks
T max
T max
Measured: up to 12 weeks
Vd
Vd
Measured: up to 12 weeks
Ke
Ke
Measured: up to 12 weeks
t 1/2
t 1/2
Measured: up to 12 weeks
CL
CL
Measured: up to 12 weeks
Anti-drug antibody, ADA
Anti-drug antibody, ADA
Measured: up to 12 weeks
IFN-γ concentration
IFN-γ concentration
Measured: up to 12 weeks
peripheral blood CD8+PD-1 receptor occupying ratio
peripheral blood CD8+PD-1 receptor occupying ratio
Measured: up to 12 weeks

Timeline

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

19 Oct 2017Aug 2022

First posted14 Dec 2017
Study start19 Oct 2017
Primary completionJun 2022 (estimated)
Study completionAug 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid TumorStudies 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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03374007
Sponsor's protocol ID: Gxplore-001
Acronym: GB226
Status last verified: Mar 2021
First submitted: 6 Dec 2017
Last updated: 16 Aug 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: There is not a plan to make individual participant data available.

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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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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: With Open, Single/Multiple Dosing and Dose Escalation, Phase I Clinical Trial Scheme to Evaluate Safety, Tolerance and Pharmacokinetic Properties of Genolimzumab Injection
ClinicalTrials.gov ID: NCT03374007
Acronym / sponsor ID: GB226 / Gxplore-001
Conditions: Advanced Solid Tumor, Recurrent Solid Tumor, Lymphoma, Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 72 participants (estimated)
Lead sponsor: Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
Study start: 19 Oct 2017 (actual)
Primary completion: Jun 2022 (estimated)
Study completion: Aug 2022 (estimated)
First posted: 14 Dec 2017 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 8

Arm	Type	Receives
GB226 1mg/kg single-dose	Experimental	Biological: Geptanolimab Injection 1mg/kgGeptanolimab, 1mg/kg, i.v., single-dose
GB226 3 mg/kg single-dose	Experimental	Biological: Geptanolimab Injection 3mg/kgGeptanolimab, 3mg/kg, i.v., single-dose
GB226 10mg/kg single-dose	Experimental	Biological: Geptanolimab Injection 10mg/kgGeptanolimab 10mg/kg, i.v., single-dose
GB226 1mg/kg multiple dosing, every 2 weeks	Experimental	Biological: Geptanolimab Injection 1mg/kg, q2w6Geptanolimab, 1mg/kg, i.v., q2w6
GB226 3mg/kg multiple dosing,every 2 weeks	Experimental	Biological: Geptanolimab Injection 3mg/kg, q2w6Geptanolimab, 3mg/kg, i.v., q2w6
GB226 10mg/kg multiple dosing, every 2 weeks	Experimental	Biological: Geptanolimab Injection 10mg/kg, , q2w6Geptanolimab,10mg/kg, i.v., q2w6
GB226 280mg multiple dosing	Experimental	Biological: Geptanolimab Injection 280mg, q3wGeptanolimab, 280mg, i.v., q3w
GB226 3mg/kg multiple dosing	Experimental	Biological: Geptanolimab Injection 3mg/kg, q2wGeptanolimab, 3mg/kg, i.v., q2w

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

1. Age: 18-65. Unisex.
2. Understand trial procedure and content and sign informed consent voluntarily;
3. Patients of advanced (phase Ⅲb, multidisciplinary treatment is not appropriate), metastatic (phase IV) or recurrent solid tumor (including melanoma, NSCLC, renal cell carcinoma, head \& neck cancer, esophagus cancer, liver cancer, bladder cancer, spongioblastoma) or lymphoma (classical hodgkin lymphoma and (or) peripheral T-cell lymphoma, natural killer (NK)-T cell lymphoma and mediastinal B cell lymphoma) conformed by histology or cytology and cannot be cured by surgery. There is no effective standard treatment now.
4. Agree to provide recorded tumor tissue sample or fresh tissue sample.
5. Eastern Cooperative Oncology Group (ECOG): 0-1;

Key exclusion criteria (11 listed)

1. Active central nervous system metastasis; If central nervous system (CNS) metastasis of patients can be treated and their symptoms of nervous system can recover to the baseline level (excluding residual signs or symptoms related to CNS treatment) for 2 weeks when they are included, they can participate in the research. Cranial CT or MRI scanning shall be made for the patients 30 days before inclusion.
2. Meningeal metastases or meningeal infiltration of tumors;
3. Patients with other malignant tumors (excluding cured cervical carcinoma in situ and skin basal cell carcinoma) shall not participate in the research, unless he/she has been fully relieved at least 2 years without the need of other treatment or other treatment is not needed during the research.
4. With active, known or suspected autoimmune disease.
5. With previous usage of PD-1 antibody, PD-L1 antibody, PD-L2 antibody or cytotoxic T-lymphocyte-associated antigen-4 immunoglobulin (CTLA-4) antibody for treatment (or other antibody for co-stimulation or check point assess of T cells)

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
Geptanolimab Injection 1mg/kgAlso: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionsingle-dose:1mg/kg	Biological	GB226 1mg/kg single-dose
Geptanolimab Injection 3mg/kgAlso: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionsingle-dose: 3mg/kg	Biological	GB226 3 mg/kg single-dose
Geptanolimab Injection 10mg/kgAlso: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionsingle-dose:10mg/kg	Biological	GB226 10mg/kg single-dose
Geptanolimab Injection 1mg/kg, q2w6Also: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionmultiple dosing: 1mg/kg, q2w6	Biological	GB226 1mg/kg multiple dosing, every 2 weeks
Geptanolimab Injection 3mg/kg, q2w6Also: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionmultiple dosing: 3mg/kg, q2w6	Biological	GB226 3mg/kg multiple dosing,every 2 weeks
Geptanolimab Injection 10mg/kg, , q2w6Also: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionmultiple dosing: 10mg/kg, , q2w6	Biological	GB226 10mg/kg multiple dosing, every 2 weeks
Geptanolimab Injection 280mg, q3wAlso: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionmultiple dosing: 280mg, q3w	Biological	GB226 280mg multiple dosing
Geptanolimab Injection 3mg/kg, q2wAlso: Recombinant PD-1 humanized monoclonal antibody injection, Geptanolimab Injectionmultiple dosing: 3mg/kg, q2w	Biological	GB226 3mg/kg multiple dosing

Primary outcome

adverse event
Time frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
adverse event
Serious Adverse Event
Time frame: all serious adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.
Serious Adverse Event
Dose limiting Toxicity, DLT
Time frame: Day 1 to Day 28 after first dose
Dose limiting Toxicity, DLT
Maximum Tolerated Dose, MTD
Time frame: Day 1 to Day 28 after first dose
Maximum Tolerated Dose, MTD

11 secondary outcomes

AUC 0-t
Time frame: up to 12 weeks
C max
Time frame: up to 12 weeks
AUC 0-∞
Time frame: up to 12 weeks
T max
Time frame: up to 12 weeks
Vd
Time frame: up to 12 weeks
Ke
Time frame: up to 12 weeks
t 1/2
Time frame: up to 12 weeks
CL
Time frame: up to 12 weeks
Anti-drug antibody, ADA
Time frame: up to 12 weeks
IFN-γ concentration
Time frame: up to 12 weeks
peripheral blood CD8+PD-1 receptor occupying ratio
Time frame: up to 12 weeks

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Individual participant dataSharing planned: No. There is not a plan to make individual participant data available.

Related trials for Advanced Solid Tumor

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
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

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

Yuankai Shi, Doctor principal investigator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 11 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 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

adverse event (time frame: all adverse events will be recorded from the time the consent form is signed through 30 days following cessation of treatment.). The study lists 4 primary outcomes in all. 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 NCT03374007.

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 16 Aug 2021.