Advanced MelanomaPhase 1NCT02738489
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 in Patients With Advanced Melanoma
A Phase 1 study testing SHR-1210 in people with Advanced Melanoma, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced melanoma with disease progression after standard treatment, unresectable lesions, or metastases. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- SHR-1210
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2016to 8 Jan 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged 18-70 years old, who agree to provide pathological tumor biopsy specimens during the screening period and after the end of treatment.
- Patients with pathologically confirmed advanced melanoma who have failed standard treatments or without effective treatment methods (e.g., chemotherapy, targeted therapy and immunotherapy other than those targeting PD-1/PD-L1).
- ECOG PS: 0-1.
- Life expectancy ≥ 12 weeks.
- With measurable and evaluable lesion(s) according to RECIST v1.1.
Who cannot join
- Patients with active autoimmune diseases or a history of autoimmune diseases (including but not limited to the following: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism; adults with vitiligo or completely relieved childhood asthma can be enrolled if they do not require any intervention; patients with asthma requiring medical intervention with bronchodilators cannot be enrolled).
- Patients who are currently using immunosuppressive agents, or systemic or absorbable local hormonal therapies for immunosuppression purposes (> 10 mg/day prednisone or equivalent) and still use the above drugs within 2 weeks prior to enrollment.
- Patients who are known to be previously allergic to macromolecular protein preparations or any component of SHR-1210.
- Patients with clinically symptomatic metastases to central nervous system (e.g., cerebral edema requiring hormonal intervention, or progression of brain metastasis). Patients who have received treatment for brain or meningeal metastasis can be included if they are clinically stable (MRI) for at least 2 months and have discontinued systemic hormonal therapy (> 10 mg/day prednisone or equivalent) for more than 2 weeks.
- Patients who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy with an interval of less than 4 weeks from the completion of the treatment to the study medication (for patients who have previously received chemotherapy with nitrosourea or mitomycin, the interval from the end of chemotherapy to the study enrollment is less than 6 weeks); patients whose adverse events caused by previous treatments have not recovered to CTCAE Grade ≤ 1.
- Patients with active infection or unexplained fever > 38.5 °C during screening or prior to the first dose (patients with tumor-induced fever may be enrolled as per the judgment of the investigator).
- Patients with congenital or acquired immunodeficiency (such as HIV, HBV, or HCV).
- Patients who have previously received other PD-1 antibody treatments or immunotherapies targeting PD-1/PD-L1.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Affiliated to Beijing University
Beijing, Beijing Municipality
About this study
Official title: An Open-Label, Single Center, Nonrandomized, Dose-Escalation Phase 1 Study to Evaluate Safety and Tolerability of SHR-1210 in Subjects With Advanced Melanoma
This is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced melanoma with disease progression after standard treatment, unresectable lesions, or metastases. Between Apr 13, 2016, and Jan 8, 2020, 36 patients were enrolled from Beijing Cancer Hospital.
- Conditions
- Advanced Melanoma
- Being tested
- SHR-1210
- Keywords
- PD-1/PD-L1 Advanced Melanoma Immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-1210Biological
A fully human monoclonal immunoglobulin (IgG4 subtype)
| Study group | Role | What they receive |
|---|---|---|
| Injection SHR-1210 60mg Cohort | Experimental | Not described Receives: Biological: SHR-1210 |
| Injection SHR-1210 200mg Cohort | Experimental | Not described Receives: Biological: SHR-1210 |
| Injection SHR-1210 400mg Cohort | Experimental | Not described Receives: Biological: SHR-1210 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Adverse Events (AEs)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
Measured: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)
Number of Participants Experiencing Severe AEs (SAEs)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
Measured: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)
Secondary outcomes (16)
Maximum Observed Serum Concentration (Cmax) For SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Area Under the Serum Concentration-time Curve to infinite time (AUC 0-inf) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Area Under the Serum Concentration-time Curve from dosing to the time of the last measured concentration (AUC 0-last) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Time to Maximum Concentration (Tmax) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Half-life (T½) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Clearance (Cl) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Volume of distribution (Vd) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Mean Residence Time (MRT) for SHR-1210
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
C(ss, Max) of SHR-1210 after Multiple Dosing
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
C(ss, Min) of SHR-1210 after Multiple Dosing
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Accumulation ratio based on Cmax (Rac, Cmax) of SHR-1210 after Multiple Dosing
Measured: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
PD-1 receptor occupancy (RO) for SHR-1210
Receptor occupancy (RO) assays are designed to quantify the binding of therapeutics to their targets on the cell surface and are frequently used to generate pharmacodynamic (PD) biomarker data in nonclinical and clinical studies of biopharmaceuticals.
Measured: PD blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Number of Participants with Anti-drug Antibodies (ADAs) for SHR-1210
ADAs: Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs.
Measured: Blood samples for ADAs analysis are collected on Cycle 1 (each cycle is 28 days) Day1 to the end of treatment (Up to 3 years and 9 months).
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the study whose best overall response was either complete response (CR) or partial response (PR) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Measured: Up to 3 years and 9 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants in the study whose best overall response was either CR, PR or stable disease (SD) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Measured: Up to 3 years and 9 months
Progression-free survival (PFS)
PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations. Median PFS was calculated by Kaplan-Meier method.
Measured: Up to 3 years and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start13 Apr 2016
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiding Xing, Doctor, Study director, Jiangsu Hengrui Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738489
- Sponsor's protocol ID
- SHR-1210-102
- Status last verified
- Feb 2023
- First submitted
- 10 Apr 2016
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Zhou L, Wu X, Chi Z, Si L, Sheng X, Kong Y, Mao L, Lian B, Tang B, Yan X, Wang X, Bai X, Li S, Wei X, Li J, Yang Q, Guo J, Cui C. Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study. BMC Cancer. 2022 May 20;22(1):565. doi: 10.1186/s12885-022-09663-5.
PubMed 35596181
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single Center, Nonrandomized, Dose-Escalation Phase 1 Study to Evaluate Safety and Tolerability of SHR-1210 in Subjects With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT02738489
- Acronym / sponsor ID
- SHR-1210-102
- Conditions
- Advanced Melanoma
- Keywords
- PD-1/PD-L1 Advanced Melanoma Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Apr 2016 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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 is an open-label, single center, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced melanoma with disease progression after standard treatment, unresectable lesions, or metastases. Between Apr 13, 2016, and Jan 8, 2020, 36 patients were enrolled from Beijing Cancer Hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection SHR-1210 60mg Cohort | Experimental | Biological: SHR-1210 |
| Injection SHR-1210 200mg Cohort | Experimental | Biological: SHR-1210 |
| Injection SHR-1210 400mg Cohort | Experimental | Biological: SHR-1210 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients aged 18-70 years old, who agree to provide pathological tumor biopsy specimens during the screening period and after the end of treatment.
- Patients with pathologically confirmed advanced melanoma who have failed standard treatments or without effective treatment methods (e.g., chemotherapy, targeted therapy and immunotherapy other than those targeting PD-1/PD-L1).
- ECOG PS: 0-1.
- Life expectancy ≥ 12 weeks.
- With measurable and evaluable lesion(s) according to RECIST v1.1.
Key exclusion criteria (8 listed)
- Patients with active autoimmune diseases or a history of autoimmune diseases (including but not limited to the following: interstitial pneumonitis, uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism; adults with vitiligo or completely relieved childhood asthma can be enrolled if they do not require any intervention; patients with asthma requiring medical intervention with bronchodilators cannot be enrolled).
- Patients who are currently using immunosuppressive agents, or systemic or absorbable local hormonal therapies for immunosuppression purposes (> 10 mg/day prednisone or equivalent) and still use the above drugs within 2 weeks prior to enrollment.
- Patients who are known to be previously allergic to macromolecular protein preparations or any component of SHR-1210.
- Patients with clinically symptomatic metastases to central nervous system (e.g., cerebral edema requiring hormonal intervention, or progression of brain metastasis). Patients who have received treatment for brain or meningeal metastasis can be included if they are clinically stable (MRI) for at least 2 months and have discontinued systemic hormonal therapy (> 10 mg/day prednisone or equivalent) for more than 2 weeks.
- Patients who have previously received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy with an interval of less than 4 weeks from the completion of the treatment to the study medication (for patients who have previously received chemotherapy with nitrosourea or mitomycin, the interval from the end of chemotherapy to the study enrollment is less than 6 weeks); patients whose adverse events caused by previous treatments have not recovered to CTCAE Grade ≤ 1.
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 |
|---|---|---|
| SHR-1210A fully human monoclonal immunoglobulin (IgG4 subtype) | Biological | Injection SHR-1210 200mg Cohort, Injection SHR-1210 400mg Cohort, Injection SHR-1210 60mg Cohort |
Primary outcome
Number of Participants Experiencing Adverse Events (AEs)
Time frame: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
Number of Participants Experiencing Severe AEs (SAEs)
Time frame: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version [v] 4.03 2010).
16 secondary outcomes
Maximum Observed Serum Concentration (Cmax) For SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Area Under the Serum Concentration-time Curve to infinite time (AUC 0-inf) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Area Under the Serum Concentration-time Curve from dosing to the time of the last measured concentration (AUC 0-last) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Time to Maximum Concentration (Tmax) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Half-life (T½) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Clearance (Cl) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Volume of distribution (Vd) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Mean Residence Time (MRT) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
C(ss, Max) of SHR-1210 after Multiple Dosing
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
C(ss, Min) of SHR-1210 after Multiple Dosing
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Accumulation ratio based on Cmax (Rac, Cmax) of SHR-1210 after Multiple Dosing
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
PD-1 receptor occupancy (RO) for SHR-1210
Time frame: PD blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 9 months).
Number of Participants with Anti-drug Antibodies (ADAs) for SHR-1210
Time frame: Blood samples for ADAs analysis are collected on Cycle 1 (each cycle is 28 days) Day1 to the end of treatment (Up to 3 years and 9 months).
Objective Response Rate (ORR)
Time frame: Up to 3 years and 9 months
Disease Control Rate (DCR)
Time frame: Up to 3 years and 9 months
Progression-free survival (PFS)
Time frame: Up to 3 years and 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 35596181Zhou L, Wu X, Chi Z, Si L, Sheng X, Kong Y, Mao L, Lian B, Tang B, Yan X, Wang X, Bai X, Li S, Wei X, Li J, Yang Q, Guo J, Cui C. Safety, activity, and pharmacokinetics of camrelizumab in advanced Asian melanoma patients: a phase I study. BMC Cancer. 2022 May 20;22(1):565. doi: 10.1186/s12885-022-09663-5.
- Individual participant dataSharing planned: Undecided
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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.
Yiding Xing, Doctor study director
Jiangsu Hengrui Pharmaceutical Co., Ltd.
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 SHR-1210 in people with Advanced Melanoma, run by Jiangsu HengRui Medicine 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 28 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Adverse Events (AEs) (time frame: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 9 months)). The study lists 2 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 NCT02738489, 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 28 Feb 2023.