Solid TumorsPhase 1NCT02857166
Study of JS001 in Participants With Advanced Solid Tumors
A Phase 1 study testing humanized anti-PD-1 monoclonal antibody toripalimab in people with Solid Tumors, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- humanized anti-PD-1 monoclonal antibody toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Dec 2018
- 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
- Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.
- at least one prior chemotherapy regimen
- age between 18 and 75 years, both gender
- has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V1.1)
- life expectancy ≥ 3 months
- ECOG performance status of 0 or 1
Show all 19Show fewer
- Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.
- Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.
- Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS001.
- Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS001. Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS001.
- The lab examination results of the screening must fulfill all of the following:
- absolute neutrophil count more than or equal to 1.5×109/ L
- platelet count more than or equal to 90×109/ L
- hemoglobin more than or equal to 90 g/L
- creatinine less than or equal to132.6µmol/L or creatinine clearance >40 mL/min
- aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 3.0 ×ULN
- total bilirubin less than or equal to 1.5×ULN( except for the patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to 51.3µmol/L)
- Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study related activities.
- Able to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
- Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
- Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.
Show all 17Show fewer
- Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.
- Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.
- Has an active infection requiring systematic therapy.
- Is positive for Human Immunodeficiency Virus (HIV).
- Has active Tuberculosis.
- Has known active Hepatitis B or C.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.
- Is pregnant or breastfeeding.
- Cannot tolerate vein puncture and / or venous access.
- Any other conclusive medical reasons, mental illness, and / or social reasons that determined by the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IA Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors.
Read the detailed description
OVERVIEW
This is a Phase 1, open-label, dose-escalation study of JS-001, a humanized monoclonal IgG4 antibody targeting the Programmed Death -1 (PD-1). It is estimated that 12-24 subjects with advanced or recurrent solid tumors or will be enrolled in the study.
A 3+3 design will be utilized for this Phase 1 study. Four dose levels are planned and include: 0.3, 1, 3, 10 mg/kg/dose. Each of the 4 dose levels will use 2 dose schedules: single dose, repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
The study will be the traditional 3 + 3 design with 3 or 6 subjects treated at this dose level and at all subsequent dose levels depending upon the incidence of DLTs. If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and the previous lower (tolerated) dose level will be considered the MTD.
A DLT is defined as a Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in a single dose cohort.
Tumor response will be evaluated using immune-related response criteria (irRC), WHO criteria , Response Evaluation Criteria in Solid Tumors (RECIST), immune-related RECIST, and International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas (for lymphomas only).
In the absence of confirmed disease progression and intolerable toxicities, subjects in the single dose cohorts and multiple dose cohorts will be allowed to continue JS-001 administration with the consent of the subject.
DOSAGE AND ADMINISTRATION
JS-001 will be administered as a 60-minute i.v. infusion. Cohorts will include escalating dose levels of 0.3, 1, 3, 10mg/kg/dose.
SAFETY EVALUATIONS
Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, diagnostic imaging, physical examinations, electrocardiograms, and the incidence and severity of adverse events.
Safety will also include evaluations of immune safety and immunogenicity. Particular attention will be given to adverse events that may follow enhanced T-cell activation such as dermatitis and colitis, uveitis, or other immune-related adverse events (irAEs).
An irAE is a clinically significant adverse event of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism.
EFFICACY EVALUATIONS
The primary efficacy endpoint is the best response rate (RR). Duration of response, progression-free survival, time to progression, and overall survival will also be analyzed.
PHARMACOKINETIC EVALUATIONS
Pharmacokinetic parameters include AUC, Cmax, tmax, and t½, etc. STATISTICAL METHODS The sample size for this study is not determined from power analysis. It is based on the 3+3 design for dose escalation and safety evaluation requirements.
Descriptive statistics will include: mean, standard deviation, median, and minimum and maximum values for continuous variables; frequencies and percentages for categorical variables.
The efficacy parameters will be summarized using descriptive statistics. All safety and pharmacokinetic parameters will be summarized using descriptive statistics.
- Conditions
- Solid Tumors
- Being tested
- humanized anti-PD-1 monoclonal antibody toripalimab
- Keywords
- JS001, solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
humanized anti-PD-1 monoclonal antibody toripalimabBiological
Also called JS001, TAB001
humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
| Study group | Role | What they receive |
|---|---|---|
| humanized anti-PD-1 monoclonal antibody toripalimab | Experimental | humanized anti-PD-1 monoclonal antibody is to be injected intravenously 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg until disease progresses or unacceptable tolerability occurs. Receives: Biological: humanized anti-PD-1 monoclonal antibody toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: Up to 2 approximately years
Secondary outcomes (17)
Anti-Drug Antibody of JS001 in Chinese patients
Measured: Cycle 1,2,3,5 Day 1 before JS001 infusion and 336 hours after last JS001 infusion, each cycle is 28 days.
Objective Response Rate (ORR)
Measured: Up to 2 approximately years
Duration of Response (DOR)
Measured: Up to 2 approximately years
Progression-Free survival (PFS)
Measured: Up to 2 approximately years
Overall Survival (OS)
Measured: Up to 2 approximately years
DLT in patients with solid tumor treated with JS001.
Measured: Cycle 1（each cycle is 28 days）
PD-1 receptor occupancy of blood
Measured: 1 year
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)
Measured: 1 year
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb
Measured: 1 year
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb Area Under the Curve [AUC]). Area Under the Curve (AUC) after single dose injection of Recombinant Humanized Anti-PD-1 Monoclonal Antibody
Measured: 1 year
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb
Measured: 1 year
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb
Measured: 1 year
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb
Measured: 1 year
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1 year
Average Plasma Concentration (Cav) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1 year
Degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1 year
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruihua Xu, MD, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02857166
- Sponsor's protocol ID
- Junshi-JS001-ZSZL-I
- Status last verified
- Oct 2019
- First submitted
- 27 Jul 2016
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IA Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Recombinant Humanized Anti-PD-1 Monoclonal Antibody (JS001) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT02857166
- Acronym / sponsor ID
- Junshi-JS001-ZSZL-I
- Conditions
- Solid Tumors
- Keywords
- JS001, solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Aug 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.
The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors.
Detailed description
OVERVIEW
This is a Phase 1, open-label, dose-escalation study of JS-001, a humanized monoclonal IgG4 antibody targeting the Programmed Death -1 (PD-1). It is estimated that 12-24 subjects with advanced or recurrent solid tumors or will be enrolled in the study.
A 3+3 design will be utilized for this Phase 1 study. Four dose levels are planned and include: 0.3, 1, 3, 10 mg/kg/dose. Each of the 4 dose levels will use 2 dose schedules: single dose, repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
The study will be the traditional 3 + 3 design with 3 or 6 subjects treated at this dose level and at all subsequent dose levels depending upon the incidence of DLTs. If no DLTs occur in a cohort of 3 subjects, a new cohort of 3 subjects will be treated at the next higher dose level. If 1 of 3 subjects in a cohort experiences a DLT, that cohort will be expanded to 6 subjects. If only 1 of the 6 subjects has a DLT, then the next cohort of 3 subjects will be treated at the next higher dose level. If 2 or more DLTs occur within a cohort, then that dose level will be above the MTD (the highest dose where no more than 1 of 6 subjects has experienced a DLT), and the previous lower (tolerated) dose level will be considered the MTD.
A DLT is defined as a Grade 3 drug-related adverse event occurring within the first cycle (28 days) of dosing (excluding tumor flare defined as local pain, irritation, or rash localized at sites of known or suspected tumor or a transient Grade 3 infusion adverse event) using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 in a single dose cohort.
Tumor response will be evaluated using immune-related response criteria (irRC), WHO criteria , Response Evaluation Criteria in Solid Tumors (RECIST), immune-related RECIST, and International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas (for lymphomas only).
In the absence of confirmed disease progression and intolerable toxicities, subjects in the single dose cohorts and multiple dose cohorts will be allowed to continue JS-001 administration with the consent of the subject.
DOSAGE AND ADMINISTRATION
JS-001 will be administered as a 60-minute i.v. infusion. Cohorts will include escalating dose levels of 0.3, 1, 3, 10mg/kg/dose.
SAFETY EVALUATIONS
Assessment of safety will be determined by vital sign measurements, clinical laboratory tests, Eastern Cooperative Oncology Group (ECOG) performance status evaluations, diagnostic imaging, physical examinations, electrocardiograms, and the incidence and severity of adverse events.
Safety will also include evaluations of immune safety and immunogenicity. Particular attention will be given to adverse events that may follow enhanced T-cell activation such as dermatitis and colitis, uveitis, or other immune-related adverse events (irAEs).
An irAE is a clinically significant adverse event of any organ that is associated with drug exposure, of unknown etiology, and is consistent with an immune-mediated mechanism.
EFFICACY EVALUATIONS
The primary efficacy endpoint is the best response rate (RR). Duration of response, progression-free survival, time to progression, and overall survival will also be analyzed.
PHARMACOKINETIC EVALUATIONS
Pharmacokinetic parameters include AUC, Cmax, tmax, and t½, etc. STATISTICAL METHODS The sample size for this study is not determined from power analysis. It is based on the 3+3 design for dose escalation and safety evaluation requirements.
Descriptive statistics will include: mean, standard deviation, median, and minimum and maximum values for continuous variables; frequencies and percentages for categorical variables.
The efficacy parameters will be summarized using descriptive statistics. All safety and pharmacokinetic parameters will be summarized using descriptive statistics.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| humanized anti-PD-1 monoclonal antibody toripalimab | Experimental | Biological: humanized anti-PD-1 monoclonal antibody toripalimabhumanized anti-PD-1 monoclonal antibody is to be injected intravenously 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg until disease progresses or unacceptable tolerability occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.
- life expectancy ≥ 3 months
- ECOG performance status of 0 or 1
- Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade 1 or better from the AEs due to the chemotherapy.
- Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS001.
Key exclusion criteria (17 listed)
- Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS001.
- Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
- Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
- Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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 |
|---|---|---|
| humanized anti-PD-1 monoclonal antibody toripalimabAlso: JS001, TAB001humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically. | Biological | humanized anti-PD-1 monoclonal antibody toripalimab |
Primary outcome
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: Up to 2 approximately years
17 secondary outcomes
Anti-Drug Antibody of JS001 in Chinese patients
Time frame: Cycle 1,2,3,5 Day 1 before JS001 infusion and 336 hours after last JS001 infusion, each cycle is 28 days.
Objective Response Rate (ORR)
Time frame: Up to 2 approximately years
Duration of Response (DOR)
Time frame: Up to 2 approximately years
Progression-Free survival (PFS)
Time frame: Up to 2 approximately years
Overall Survival (OS)
Time frame: Up to 2 approximately years
DLT in patients with solid tumor treated with JS001.
Time frame: Cycle 1（each cycle is 28 days）
PD-1 receptor occupancy of blood
Time frame: 1 year
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)
Time frame: 1 year
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb
Time frame: 1 year
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb Area Under the Curve [AUC]). Area Under the Curve (AUC) after single dose injection of Recombinant Humanized Anti-PD-1 Monoclonal Antibody
Time frame: 1 year
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb
Time frame: 1 year
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb
Time frame: 1 year
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb
Time frame: 1 year
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1 year
Average Plasma Concentration (Cav) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1 year
Degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1 year
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb
Time frame: 1 year
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 23 Oct 2019.
- Individual participant dataSharing planned: No
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Solid Tumors
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.
Ruihua Xu, MD, PhD principal investigator
Sun Yat-sen University
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 humanized anti-PD-1 monoclonal antibody toripalimab in people with Solid Tumors, run by Shanghai Junshi Bioscience 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 19 inclusion and 17 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 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: Up to 2 approximately years). 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 23 Oct 2019.