Metastatic Non-small Cell Lung CancerPhase 1NCT03976856
Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib
A Phase 1 study testing GB226 and Fruquintinib in people with Metastatic Non-small Cell Lung Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- GB226 and Fruquintinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2019to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years, male or female;
- Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form;
- Histologically or cytology confirmed relapsed or metastatic NSCLC;
- EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). Moreover, the following conditions are met:
- No T790M mutation after failure of EGFR-TKI treatment;
- T790M mutation after EGFR-TKI treatment failure, and failed to respond to third-generation EGFR-TKI treatment; primary T790M mutation, progressed after third-generation EGFR-TKI treatment or no other available effective therapies;
Show all 31Show fewer
- The above patients failed to respond to chemotherapy or are unwilling to or intolerable to chemotherapy;
- According to the RECIST 1.1 criteria, at least one target lesion (the lesion with a longest diameter ≥10 mm, or a lymph node with a short diameter ≥15 mm) are measured by CT or MRI;
- Expected survival ≥ 3 months;
- ECOG score: 0-1;
- Completion of systemic chemotherapy, radical/extensive therapy, or previous anti-tumor biological therapies (tumor vaccine, cytokine or growth factor for the purpose of tumor control) for at least 4 weeks, completion of local palliative radiotherapy for at least 1 week;
- The EGFR-TKI treatment has ended over 2 weeks before the use of study drugs;
- Patients who have not previously received treatment with TKI or monoclonal antibodies against Vascular Endothelial Growth Factor (VEGF) and/or VEGFR;
- At least 8 weeks after completion of major surgery requiring general anesthesia before the use of study drugs; at least 4 weeks after completion of surgery requiring local anesthesia/epidural anesthesia and recovery from the surgery;
- Discontinuation of systemic corticosteroids for at least 2 weeks before the use of study drugs (prednisone > 10 mg/day or equivalent dose);
- The values of the laboratory tests performed for screening must meet the following criteria:
- Blood routine test results(no blood transfusion, G-CSF or other drugs for correction within 14 days before screening):
- Hemoglobin HGB ≥90g/L;
- Absolute neutrophil count (ANC) ≥1.5x10^9/L;
- Platelet count PLT ≥100x10^9/L;
- Clinical biochemistry:
- Total bilirubin (TBIL) ≤1.5 times the upper limit of normal [ULN] [≤1.5 times for Gilbert syndrome);
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the ULN (AST and/or ALT ≤5×ULN for patients with liver metastases);
- Serum creatinine ≤ 1.5 × ULN or endogenous creatinine clearance rate≥ 50 mL/min (Cockcroft-Gault formula)
- Urine protein ˂ 2+ or ˂1.0 g/L. For patients with baseline urinary protein ≥ 2+ or ≥ 1.0 g/L, a 24-hour urine protein quantitative test should be performed, and the result should be ≤ 1.0 g/L;
- Coagulation Function:
- a)Activated partial thromboplastin time (APTT) or prothrombin time (PT) ≤1.5 times ULN
- Thyroid function variables: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) within the normal range;
- Recovery of adverse reactions caused by previous treatment to grade 1 and below before enrollment (except hair loss and ≤grade 2 neurotoxicity caused by chemotherapeutic agents);
- Women who are confirmed not pregnant within within 7 days before administration; male or female subjects who are able to father or bear a child agree to take medically recognized effective contraceptive measures throughout the study period and within six months of completion of the study;
- Consent to provide tissue samples and receive biopsy if necessary.
Who cannot join
- Patients with lung squamous cell carcinoma (including adenosquamous carcinoma);
- ALK fusion gene rearrangement confirmed by genetic testing;
- Patients with history of other malignant tumors (except cured cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma) may not participate in the study unless the diseases have been cured for at least 5 years prior to enrollment, and it is estimated that no other treatment will be required throughout the study;
- Detection of the tumor lesion ≤ 5 mm from the large vessel, or a central tumor that invaded the local large vessel; or a significant pulmonary cavity or necrotizing tumor by imaging (CT or MRI);
- Active central nervous system (CNS) metastasis, including symptomatic brain metastasis, meningeal metastasis or spinal cord compression; patients with asymptomatic brain metastases can be enrolled (no progression and/or neurological symptoms or signs after surgical resection within at least 4 weeks after radiotherapy, no history of treatment with glucocorticoids, anticonvulsants or mannitol);
- Symptomatic, uncontrollable serous effusions such as ascites, pleural effusion, or pericardial effusion;
Show all 23Show fewer
- History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollment, evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity;
- Patients with thrombolytic therapy or therapeutic anticoagulant drugs (except prophylactic anticoagulant drugs) within 10 days before the first study drug;
- History of active, known autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, except type I diabetes, hypothyroidism that can be controlled by hormone replacement therapy only, skin diseases not requiring systemic treatment (such as vitiligo and psoriasis) and controlled celiac disease.
- Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies (or any other antibodies that act on T-cell costimulatory or checkpoint pathways);
- Uncontrolled hypertension (systolic blood pressure﹥140mmHg and/or diastolic blood pressure﹥90mmHg), pulmonary hypertension or unstable angina; myocardial infarction, bypass surgery or stent surgery within 6 months before administration of drug; history of chronic heart failure that meets the criteria for grade 3-4 defined by New York Heart Association (NYHA); severe arrhythmia requiring treatment, including QTc interval ≥450ms for male subjects and ≥ 470ms for female subjects (calculated by Fridericia formula); left ventricular ejection fraction (LVEF) <50%; cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration of drug;
- Skin wounds, surgical site, wound site, severe mucosal ulcers or fractures that are not completely healed;
- Dysphagia or gastrointestinal disorders that may significantly affect absorption of oral drugs or any conditions that may cause gastrointestinal bleeding or perforation at the discretion of the investigator (such as duodenal ulcer, gastrointestinal obstruction, diverticulitis, intraperitoneal abscess, metastasis of peritoneal carcinoma, acute Crohn's disease, ulcerative colitis, large area stomach and small bowel resection). Patients with chronic Crohn's disease and ulcerative colitis (except total colon and rectal resection) should be excluded even during inactivity period. Patients with hereditary nonpolyposis colorectal cancer or familial adenomatous polyposis syndrome; patients with history of intestinal perforation and intestinal fistula who are not recovered after surgery;
- Previouly or currently suffered from active tuberculosis infection, or other infections requiring systemic treatment;
- Positive human immunodeficiency virus antibody (HIV-Ab), treponema pallidum antibody (TP-Ab) or hepatitis C antibody (HCV-Ab); positive hepatitis B virus surface antigen (HBsAg), and hepatitis B virus DNA copy number > upper limit of normal of the testing institution;
- Complications requiring treatment with immunosuppressive drugs or requiring systemic use of doses with immunosuppressive effects (prednisone >10 mg/day or equivalent dose of similar drugs); in the absence of active autoimmune disease, it is allowed to inhale or topically use steroids and prednisone >10mg/day or similar drugs at an equivalent dose.
- History of interstitial lung disease;
- Received treatment with other study drugs within 30 days before administration of the study drug or before 5 half-lives of other study drugs (whichever is longer); or use of investigational device within 30 days;
- Live vaccines or attenuated vaccines are expected to be administered within 4 weeks before administration, during treatment period or within 5 months after the last dose;
- History of drug addiction or drug abuse upon inquiry;
- Breastfeeding women;
- Known allergy to recombinant humanized PD-1 monoclonal antibody or any of its excipients; known allergy to analogues of fruquintinib; known history of allergic diseases or severe allergic constitution;
- Other circumstances based on which the investigator believes that the subject is not suitable for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai chest hospital
Shanghai, Shanghai Municipality, 200000
shun lu, doctor, 021-22200000, shun_lu@hotmail.com
About this study
Official title: A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients
This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.
Read the detailed description
In this study, it is planned to enroll at least 42 NSCLC patients who meet relevant criteria. This study includes dose escalation phase and extension phase of the combined therapy: three combined dose groups are planned in the dose escalation phase; the dose extension phase is divided into two cohorts.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- GB226, Fruquintinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB226Drug
Also called Geptanolimab
Geptanolimab, 210mg，q2w，ivgtt.
FruquintinibDrug
Also called HMPL-013
Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off
| Study group | Role | What they receive |
|---|---|---|
| GB226+Fruquintinib | Experimental | Geptanolimab combined with Fruquintinib Receives: Drug: GB226; Drug: Fruquintinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event
Assessment of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
Incidence of Serious Adverse Event
Assessment of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Measured: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
Dose Limited Toxicity
Incidence of Dose Limited Toxicity
Measured: Day 1 to Day 28 after first dose
Maximum Tolerated Dose
Defined as the highest dose tested in which only 0 or 1 out of 6 evaluable patients experience a dose limiting toxicity, as graded by the National Cancer Institute (NCI) Common terminology Criteria for Adverse Events (CTCAE) version 4.03
Measured: Day 1 to Day 28 after first dose
Secondary outcomes (17)
Cmax
Cmax
Measured: up to 90 days after the last administration
Tmax
Tmax
Measured: up to 90 days after the last administration
AUC0-t
AUC0-t
Measured: up to 90 days after the last administration
AUC0-∞
AUC0-∞
Measured: up to 90 days after the last administration
MRT
MRT
Measured: up to 90 days after the last administration
Vd
Vd
Measured: up to 90 days after the last administration
CL
CL
Measured: up to 90 days after the last administration
AUC 0-τ
AUC 0-τ
Measured: up to 90 days after the last administration
C avg
C avg
Measured: up to 90 days after the last administration
C min
C min
Measured: up to 90 days after the last administration
CL ss
CL ss
Measured: up to 90 days after the last administration
Objective Response Rate, ORR
To evaluate the efficacy of GB226 as defined by objective response rate in patients with lung cancer.
Measured: up to 90 days after the last administration
Disease control rate,DCR
To evaluate the efficacy of GB226 as defined by disease control rate in patients with lung cancer.
Measured: up to 90 days after the last administration
Duration of response, DOR
To evaluate the duration of response (DOR) of GB226 in patients with lung cancer
Measured: up to 90 days after the last administration
Progression-free survival, PFS
To evaluate the efficacy of GB226 as defined by progression-free survival in patients with lung cancer
Measured: up to 90 days after the last administration
Overall survival, OS
To evaluate the efficacy of GB226 as defined by overall survival in patients with lung cancer.
Measured: up to 90 days after the last administration
Concentration of AntiDrug Antibody, ADA
To evaluate the immunogenicity of GB226 in Chinese patients with lung cancer.
Measured: up to 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start23 Jul 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non-small Cell Lung 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Doctor, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976856
- Sponsor's protocol ID
- Gxplore-015
- Status last verified
- Mar 2021
- First submitted
- 24 May 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- A Phase Ib Clinical Study With Extension Phase to Evaluate Safety and Efficacy of Genolimzumab (GB226) in Combination With Fruquintinib in the Treatment of Relapsed or Metastatic NSCLC Patients
- ClinicalTrials.gov ID
- NCT03976856
- Acronym / sponsor ID
- Gxplore-015
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Hutchison Medipharma Limited
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jun 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.
This study is a multi-center, open-label, dose-finding phase Ib clinical study with extension phase, which is aimed at evaluating the efficacy and safety of GB226 combined with fruquintinib in treatment of relapsed or metastatic NSCLC patients with EGFR-sensitive mutations who have failed to respond to EGFR-TKI treatment,evaluating the pharmacokinetic characteristics of GB226 and fruquintinib, and the immunogenicity of GB226, and preliminarily evaluating the antitumor activity of GB226 and fruquintinib.
Detailed description
In this study, it is planned to enroll at least 42 NSCLC patients who meet relevant criteria. This study includes dose escalation phase and extension phase of the combined therapy: three combined dose groups are planned in the dose escalation phase; the dose extension phase is divided into two cohorts.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GB226+Fruquintinib | Experimental | Drug: GB226, Drug: FruquintinibGeptanolimab combined with Fruquintinib |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- Aged 18-75 years, male or female;
- Understanding the procedures and contents of the study, and voluntarily signing the written informed consent form;
- Histologically or cytology confirmed relapsed or metastatic NSCLC;
- EGFR gene sensitive mutation is confirmed positive, any of following is met: exon 19 deletion (19DEL), exon 21 point mutation (L858R / L861Q), 18 exon point mutation (G719X), 20 exon point mutation (S768I). Moreover, the following conditions are met:
- According to the RECIST 1.1 criteria, at least one target lesion (the lesion with a longest diameter ≥10 mm, or a lymph node with a short diameter ≥15 mm) are measured by CT or MRI;
Key exclusion criteria (23 listed)
- Patients with lung squamous cell carcinoma (including adenosquamous carcinoma);
- ALK fusion gene rearrangement confirmed by genetic testing;
- Patients with history of other malignant tumors (except cured cervical carcinoma in situ, basal cell carcinoma of skin or squamous cell carcinoma) may not participate in the study unless the diseases have been cured for at least 5 years prior to enrollment, and it is estimated that no other treatment will be required throughout the study;
- Detection of the tumor lesion ≤ 5 mm from the large vessel, or a central tumor that invaded the local large vessel; or a significant pulmonary cavity or necrotizing tumor by imaging (CT or MRI);
- Active central nervous system (CNS) metastasis, including symptomatic brain metastasis, meningeal metastasis or spinal cord compression; patients with asymptomatic brain metastases can be enrolled (no progression and/or neurological symptoms or signs after surgical resection within at least 4 weeks after radiotherapy, no history of treatment with glucocorticoids, anticonvulsants or mannitol);
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: GeptanolimabGeptanolimab, 210mg，q2w，ivgtt. | Drug | GB226+Fruquintinib |
| FruquintinibAlso: HMPL-013Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off | Drug | GB226+Fruquintinib |
Primary outcome
Incidence of Adverse Event
Time frame: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
Assessment of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Incidence of Serious Adverse Event
Time frame: all adverse events will be recorded from the time the consent form is signed through 90 days following cessation of treatment.
Assessment of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v4.03
Dose Limited Toxicity
Time frame: Day 1 to Day 28 after first dose
Incidence of Dose Limited Toxicity
Maximum Tolerated Dose
Time frame: Day 1 to Day 28 after first dose
Defined as the highest dose tested in which only 0 or 1 out of 6 evaluable patients experience a dose limiting toxicity, as graded by the National Cancer Institute (NCI) Common terminology Criteria for Adverse Events (CTCAE) version 4.03
17 secondary outcomes
Cmax
Time frame: up to 90 days after the last administration
Tmax
Time frame: up to 90 days after the last administration
AUC0-t
Time frame: up to 90 days after the last administration
AUC0-∞
Time frame: up to 90 days after the last administration
MRT
Time frame: up to 90 days after the last administration
Vd
Time frame: up to 90 days after the last administration
CL
Time frame: up to 90 days after the last administration
AUC 0-τ
Time frame: up to 90 days after the last administration
C avg
Time frame: up to 90 days after the last administration
C min
Time frame: up to 90 days after the last administration
CL ss
Time frame: up to 90 days after the last administration
Objective Response Rate, ORR
Time frame: up to 90 days after the last administration
Disease control rate,DCR
Time frame: up to 90 days after the last administration
Duration of response, DOR
Time frame: up to 90 days after the last administration
Progression-free survival, PFS
Time frame: up to 90 days after the last administration
Overall survival, OS
Time frame: up to 90 days after the last administration
Concentration of AntiDrug Antibody, ADA
Time frame: up to 90 days after the last administration
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.
- Individual participant dataSharing planned: No
Related trials for Metastatic Non-small Cell Lung 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
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
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.
Shun Lu, Doctor principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB226 and Fruquintinib in people with Metastatic Non-small Cell Lung 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 31 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 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?
Incidence of Adverse Event (time frame: all adverse events will be recorded from the time the consent form is signed through 90 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?
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.