Non-small Cell Lung CancerPhase 1/2NCT05859373
To Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.
A Phase 1/2 study testing TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation and TQB2450 injection, sequential or concurrent chemoradiation in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation and TQB2450 injection, sequential or concurrent chemoradiation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Dec 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-75 years (calculated based on the date of signing Informed consent form (ICF) ); male or female;
- Non resectable stage III non-small cell lung cancer (NSCLC) patients confirmed by histopathological or cytological examination；
- At least one measurable lesion (based on RECIST 1.1)；
- Has not received any systematic treatment or targeted radiotherapy for locally advanced non-small cell lung cancer;
- Eastern cooperative oncology group (ECOG) score 0-1;
- Estimated survival time ≥ 3 months;
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- The main organs function are normally, meeting following criteria:
- routine blood tests: hemoglobin (HGB) ≥80g/L (no blood transfusion and blood products within 14 days); absolute neutrophil count (ANC) ≥1.5×109/L; platelets (PLT)≥90×10^9/L.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN);Serum creatinine (CR) ≤ 1.5×ULN or creatinine clearance (CCR) ≥ 60 ml/min.
- Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
- Cardiac ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
- Female participants should have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Participants should agree that contraception must be used during the study period and for 6 months after the end of the study.
Who cannot join
- Comorbidity and medical history:
- Have had or currently have other malignant tumors within 2 years. The following two conditions can be enrolled: other malignancies treated with a single surgery; cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumors), Tis (carcinoma in situ) and T1 (tumor-invasive basement membrane)];
- Pathological types of mixed small cell and non-small cell lung cancer components；
- Patients with known EGFR/ALK mutations
- There was Therapeutic toxicity (≥ CTC AE grade 2 infection)
- Have a history of idiopathic pulmonary fibrosis, organized pneumonia, drug-induced pneumonia, or idiopathic pneumonia
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- Subjects who have received major surgical treatment or obvious traumatic injury within 4 weeks prior to initial administration
- Tumor related symptoms and treatment
- Received Antitumor traditional Chinese medicine treatment within 2 weeks before the start of research treatment；
- Previously received other PD-1/PD-L1/CTLA-4 antibody treatments or immunotherapy;
- Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage;
- Research treatment related:
- Subjects who have received the vaccine within 4 weeks prior to the first dose, or is planning to be vaccinated during the study period
- Individuals with a previous history of severe allergies to macromolecular drugs or severe hypersensitivity reactions after administration of other monoclonal antibodies
- Existence of any active autoimmune disease or history of autoimmune disease
- Subjects who have participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose
- According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons which are not suitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250117
Yuping Sun, Doctor, +86 13370582181, 13370582181@163.com
About this study
Official title: A Randomized, Open Label, Parallel Controlled, Multicenter Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.
It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer.
Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT[s]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation, TQB2450 injection, sequential or concurrent chemoradiation
- 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.
TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationCombination product
TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationCombination product
TQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
TQB2450 injection, sequential or concurrent chemoradiationCombination product
TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1).
| Study group | Role | What they receive |
|---|---|---|
| TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection | Experimental | TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance therapy of TQB2450 injection. Receives: Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation |
| TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection | Experimental | TQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance with TQB3728 tablets and TQB2450 injection for 4 cycles. Then sequential maintenance with TQB2450 injection monotherapy； Receives: Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation |
| Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection. | Active comparator | Sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance with TQB2450 injection； Receives: Combination Product: TQB2450 injection, sequential or concurrent chemoradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Measured: Baseline to 30 days after last administration.
Severity of adverse events (AEs)
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Measured: Baseline to 30 days after last administration.
Dose-limiting toxicity (DLT)
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade IV hematological toxicity, neutropenia associated with fever.
Measured: Up to 28 days.
Recommended phase II dose (RP2D)
The RP2D defined as the lower dose level to maximum tolerated dose based on the safety profile.
Measured: Baseline to 30 days after last administration.
Overall response rate (ORR)
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response (CR) and partial response (PR) by subcenter imaging evaluation. It is recorded from the first dose of the drug to disease progression or initiation of a new anticancer treatment.
Measured: Baseline to the disease progression, up to two years.
Secondary outcomes (14)
Time to reach maximum plasma concentration (Tmax)
To characterize the pharmacokinetics of TQB3728 by assessment of time to reach maximum plasma concentration.
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Peak concentration (Cmax)
Cmax is the maximum plasma concentration of TQB3728 or metabolite(s).
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Terminal half-life (t1/2)
Pharmacokinetics parameters to evaluate the half life of TQB3728.
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Area under the plasma concentration-time curve from time zero to time t.
To characterize the pharmacokinetics of TQB3728 by assessment of area under the plasma concentration time curve from zero to specific time or infinity.
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Cmax,ss is the steady state maximum concentration of TQB3728.
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Cmin,ss is the minimum plasma concentration of TQB3728.
Measured: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Disease control rate (DCR)
Percentage of subjects achieving CR and PR and stable disease (SD).
Measured: Baseline to up to two years.
Duration of Response (DOR)
The period from the subjects first achieving CR or PR to disease progression.
Measured: Baseline to up to two years.
Progression-free survival (PFS) at 12 months.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Up to 12 months.
Progression-free survival at 18 months.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Up to 18 months.
Progression-free survival.
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Measured: Baseline to the disease progression, up to two years.
Overall survival (OS) at 12 months.
OS is defined as the time from the first administration to all-cause death.
Measured: Up to 12 months.
Overall survival (OS) at 18 months.
OS is defined as the time from the first administration to all-cause death.
Measured: Up to 18 months.
Overall survival (OS)
OS is defined as the time from the first administration to all-cause death.
Measured: Baseline to the disease progression, up to two years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startJun 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859373
- Sponsor's protocol ID
- TQB3728-Ib/II-02
- Status last verified
- Mar 2023
- First submitted
- 5 May 2023
- Last updated
- 16 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Parallel Controlled, Multicenter Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3728 Tablets in Sequential Maintenance of TQB2450 Injection Therapy in Patients After Sequential or Concurrent Chemoradiation for Locally Advanced Non-small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT05859373
- Acronym / sponsor ID
- TQB3728-Ib/II-02
- Conditions
- Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 May 2023 (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.
It's a Phase Ib/II clinical trial to evaluate the efficacy and safety of TQB3728 tablets in sequential maintenance TQB2450 injection therapy in patients after sequential or concurrent chemoradiation for locally advanced non-small cell lung cancer.
Incidence and severity of adverse events (AEs), the type of dose-limiting toxicity(ies) (DLT[s]) and Recommended phaseII dose(RP2D) were the Phase Ib primary endpoint. Overall response rate (ORR) was the Phase II primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection | Experimental | Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationTQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance therapy of TQB2450 injection. |
| TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection | Experimental | Combination Product: TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationTQB3728 tablets combined with sequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance with TQB3728 tablets and TQB2450 injection for 4 cycles. Then sequential maintenance with TQB2450 injection monotherapy； |
| Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection. | Active comparator | Combination Product: TQB2450 injection, sequential or concurrent chemoradiationSequential or concurrent chemoradiation, 21 days as a treatment cycle. After 4~6 cycles, sequential maintenance with TQB2450 injection； |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Between the ages of 18-75 years (calculated based on the date of signing Informed consent form (ICF) ); male or female;
- Non resectable stage III non-small cell lung cancer (NSCLC) patients confirmed by histopathological or cytological examination；
- At least one measurable lesion (based on RECIST 1.1)；
- Has not received any systematic treatment or targeted radiotherapy for locally advanced non-small cell lung cancer;
- Eastern cooperative oncology group (ECOG) score 0-1;
Key exclusion criteria (17 listed)
- Comorbidity and medical history:
- Tumor related symptoms and treatment
- Research treatment related:
- Subjects who have participated in clinical trials of other anti-tumor drugs within 4 weeks before the first dose
- According to the judgment of the investigator, subjects with concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects with other reasons which are not suitable for inclusion.
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 |
|---|---|---|
| TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationTQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1). | Combination product | TQB3728 tablets+chemoradiation, sequential maintenance with TQB2450 injection |
| TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiationTQB3728 is an inhibitor of apoptosis protein. TQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1). | Combination product | TQB3728 tablets+chemoradiation, sequential maintenance with TQB3728 tablets and TQB2450 injection |
| TQB2450 injection, sequential or concurrent chemoradiationTQB2450 injection is humanized monoclonal antibody to Programmed Cell Death Protein 1 (PD-1). | Combination product | Sequential or concurrent chemoradiation, sequential maintenance with TQB2450 injection. |
Primary outcome
Incidence of adverse events (AEs)
Time frame: Baseline to 30 days after last administration.
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Severity of adverse events (AEs)
Time frame: Baseline to 30 days after last administration.
All adverse medical events that occur after the subject receives the investigational drug evaluated according to the National Cancer Institute standard for common toxic reactions (NCI-CTC) V5.0.
Dose-limiting toxicity (DLT)
Time frame: Up to 28 days.
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug: grade III or above of non-hematological toxicity, grade IV hematological toxicity, neutropenia associated with fever.
Recommended phase II dose (RP2D)
Time frame: Baseline to 30 days after last administration.
The RP2D defined as the lower dose level to maximum tolerated dose based on the safety profile.
Overall response rate (ORR)
Time frame: Baseline to the disease progression, up to two years.
According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, the proportion of subjects whose tumors are evaluated as complete response (CR) and partial response (PR) by subcenter imaging evaluation. It is recorded from the first dose of the drug to disease progression or initiation of a new anticancer treatment.
14 secondary outcomes
Time to reach maximum plasma concentration (Tmax)
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Peak concentration (Cmax)
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Terminal half-life (t1/2)
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Area under the plasma concentration-time curve from time zero to time t.
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss)
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Minimum steady-state plasma drug concentration during a dosage interval (Cmin,ss)
Time frame: For single dose, pre-dose, 0.5,1, 2, 3, 4, 8, 24 hours after dose; For multiple dose, pre-dose on day 3, day 5, day 7, day 14 and 0.5, 1, 2, 4, 8, 24, 48, 72 hours after dose on day14.
Disease control rate (DCR)
Time frame: Baseline to up to two years.
Duration of Response (DOR)
Time frame: Baseline to up to two years.
Progression-free survival (PFS) at 12 months.
Time frame: Up to 12 months.
Progression-free survival at 18 months.
Time frame: Up to 18 months.
Progression-free survival.
Time frame: Baseline to the disease progression, up to two years.
Overall survival (OS) at 12 months.
Time frame: Up to 12 months.
Overall survival (OS) at 18 months.
Time frame: Up to 18 months.
Overall survival (OS)
Time frame: Baseline to the disease progression, up to two years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
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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.
Cancer Hospital Affiliated to Shandong First Medical University
Jinan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TQB3728 tablets, TQB2450 injection, sequential or concurrent chemoradiation and TQB2450 injection, sequential or concurrent chemoradiation in people with Non-small Cell Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 12 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: status not confirmed, as of the sponsor's last update on 16 May 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: Baseline to 30 days after last administration.). The study lists 5 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 16 May 2023.