AML, AdultPhase 1NCT05947344
A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
A Phase 1 study testing STI-8591 in people with AML, Adult, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Adult
- What is being tested?
- STI-8591
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2023to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled in this study, subjects must meet all of the following inclusion criteria.
- Voluntary signing of ICF.
- Age ≥ 18 years old.
- Expected survival >12 weeks.
- Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS/myeloproliferative neoplasm (MPN)-associated AML (AML-MR) diagnosed by 2022 WHO AML typing and with diagnostic criteria that have failed standard therapy or are intolerant of standard therapy may be considered for inclusion in this component of the study. Dose extension section: Advanced primary AML or MDS secondary to AML or AML-MR diagnosed according to the 2022 WHO AML typing and associated diagnostic criteria, who have failed or are intolerant to standard therapy, or who are unable to access standard therapy for various reasons, may only be considered for inclusion in this part of the study.
- ECOG scores physical fitness status 0 to 2.
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- Subjects are willing to undergo a bone marrow aspiration/biopsy as required by the protocol, which is used to assess the subject's response to treatment.
- Laboratory test index requirements within 7 days prior to the first dose, including:
- White blood cell count (WBC) ≤ 20 x 109 /L [(hydroxyurea is allowed up to the first dose to stabilize the WBC count up to a maximum dose of 5 g/day. Hydroxyurea may be continued for up to 28 days after the first dose (i.e., the first dosing cycle) at the discretion of the investigator, but generally not beyond 28 days)].
- Alanine aminotransferase (ALT) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known).
- Aspartate aminotransferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN if liver involvement is known) Total bilirubin (TBIL) ≤ 1.5 x ULN (< 3.0 x ULN if diagnosed with Gilbert's syndrome) Estimated glomerular filtration rate (eGFR, calculated according to the Cockcroft-Gault formula or by measuring 24-hour urine) > 50 mL/min.
- Residual toxicity of previous antitumor therapy ≤ grade 1 (except alopecia and hyperpigmentation; see inclusion criteria 7 for laboratory test indices)
- Be willing and able to comply with the study schedule and all other study protocol requirements.
- Women of childbearing potential (WOCBP) (women of childless potential defined as sexually mature women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingo-oophorectomy or bilateral tubal ligation/closure, or who are unable to have children because of congenital or acquired disease or who have been spontaneously menopausal for ≥12 months) must have a negative blood pregnancy test performed during screening.
- Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use a highly effective method of contraception from the time of screening until 180 days after the last treatment.
- Subjects are required to provide FLT3 mutation status testing within 6 months prior to the first dose, and if not, are willing to undergo screening period testing as required by the protocol.
Who cannot join
- To be enrolled in this study, subjects must not meet any of the following exclusion criteria.
- Known hypersensitivity to any component of the study drug formulation.
- Subjects were diagnosed with acute promyelocytic leukemia (APL).
- Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).
- Subjects developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN).
- Subjects had CNS leukemia with associated clinical symptoms.
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- Enrolled in any therapeutic clinical study within 28 days prior to the first dose and enrolled in treatment, except in the survival follow-up phase of the interventional study.
- Received anti-tumor therapy (including chemotherapy, immunotherapy, endocrine therapy, targeted therapy, etc.) within 28 days or 5 half-lives (whichever is shorter) prior to the first dose. Received radiotherapy within 14 days prior to the first dose. Palliative radiotherapy for symptom control is allowed to be completed at least 7 days prior to the first dose. Have received herbal therapy with approved indications for antitumor use within 7 days prior to the first dose.
- ≥ Grade 2 graft-versus-host disease (GvHD), including acute, chronic or overlapping or escalating GvHD therapy within 14 days prior to first dose or being treated with systemic cortisol hormone for GvHD.
- Received chimeric antigen receptor T-cell immunotherapy (CAR-T) within 3 months prior to the first dose.
- Strong inducer or strong inhibitor of cytochrome P450 (CYP450) 2C8 or 3A4 enzymes taken within 14 days prior to the first dose, unless the investigator assesses that the drug is necessary for the subject's treatment regimen.
- Major surgery within 28 days prior to first dose or minor surgery within 7 days prior to first dose, except diagnostic biopsy, insertion of vascular access device
- Subjects have clinically significant coagulation abnormalities, such as disseminated intravascular coagulation (DIC), hemophilia A, hemophilia B, and vascular hemophilia.
- Intractable hypokalemia or hypomagnesemia that is not easily corrected by symptomatic treatment and with previous recurrent episodes.
- Active tuberculosis, or interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, history of radiation pneumonia, or clinically active interstitial lung disease as suggested by any current evidence, prior to the first dose.
- Presence of an uncontrolled active infection (defined as exhibiting persistent signs/symptoms associated with the infection that do not improve despite appropriate antibiotic or other treatment) within 72 hours prior to the first dose. Ongoing use of prophylactic antibiotics, antifungals, or antivirals is eligible for enrollment.
- Inability to take oral medication, history of previous surgery or severe gastrointestinal disorders such as dysphagia and active gastric ulcer, which the investigator believes may affect the absorption of the study drug.
- History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (other than thrombosis due to vascular access devices or superficial venous thrombosis) within 3 months prior to the first dose.
- Active or uncontrolled HBV (HBsAg positive and/or HBcAb positive with positive HBV-DNA titers), HCV (HCV-Ab positive with positive HCV-RNA titers), HIV positive.
- History of clinically significant cardiovascular disease, including.
- Congestive heart failure (NYHA classification ≥ Class III) within 6 months prior to first dose
- Unstable angina occurred within 6 months prior to the first dose.
- Myocardial infarction within 6 months prior to the first dose.
- Presence of poorly controlled arrhythmias at screening (e.g., subjects with ventricular tachycardia occurring during antiarrhythmic drug therapy will be excluded; however, subjects with atrioventricular block of degree I or asymptomatic left anterior bundle branch block/right bundle branch block do not have to be excluded).
- Diagnosis or suspicion of long QT syndrome at screening (including a family history of long QT syndrome)
- QTcF interval >450 msec (using the Fridericia formula).
- Left ventricular ejection fraction (LVEF) <45%.
- Uncontrolled hypertension (on the basis of lifestyle improvement, blood pressure has not reached the standard after applying a reasonably tolerable adequate dose of 2 or more antihypertensive drugs for more than 1 month, or blood pressure can be effectively controlled only after taking 4 or more antihypertensive drugs).
- Stroke, cerebrovascular accident or transient ischemic attack within 6 months prior to the first dose.
- Pregnant or lactating women.
- Any active serious mental illness, medical condition or other symptom/condition that, in the judgment of the investigator, may interfere with treatment, compliance or the ability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
Jie Jin, Doctor, 0571-87236896, jiej0503@163.com
About this study
Official title: A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study.
- Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591.
- Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.
Read the detailed description
Dose escalation phase:Based on the preclinical trial data and with reference to the modified Fibonacci method, the dose escalation ratios are 100%, 100%, 50% and 6.7%, and the initial 5 dose groups for STI-8591 dose escalation are 40, 80, 160, 240 and 280 mg/day, respectively. Screened subjects will be entered into the 5 dose groups in order of succession from lowest to highest dose.This test dose increment will be performed using the rapid titration method and the traditional 3+3 test design.
Dose expansion phase:During dose escalation, for dose groups (except for ≥2 DLT dose groups) when the following dose signals suggesting initial efficacy are present.
- CR, CRh or CRi in ≥1 subject in either dose group.2) Median decrease in FLT3 phosphorylation was ≥90% in ≥3 subjects in either dose group.The SRC will decide whether to initiate an extension study for that dose group and its subsequent dose groups at the same time as the dose escalation to the next dose group. Subjects in the dose escalation phase will be administered BID every 28 days in 1 cycle, with ≥8h between doses, fasting for at least 2 hours before and at least 1 hour after dosing with approximately 240mL of water (subject to adjustment based on data results from the dose escalation phase) . If initiation was determined, the dose group identified for initiation and its subsequent dose group extension studies were further enrolled in 14 to 17 cases [a total of 20 cases in each dose group, with FLT3 mutation-positive (FLT3 internal tandem repeat (ITD) and/or FLT3 tyrosine kinase structural domain (TKD) mutation-positive subjects enrolled in at least 10 cases] to further define the final RP2D.
- Conditions
- AML, Adult
- Being tested
- STI-8591
- Keywords
- FLT3 inhibitor
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-8591Drug
Also called STI-8591 alone
Four dosing cohorts will be evaluated in the dose escalation phase: 20mg, 40mg, 60mg and 80mg. Expansion is planned in two dose groups of 40mg and 60mg.
| Study group | Role | What they receive |
|---|---|---|
| STI-8591 in Advanced Acute Myeloid Leukemia (AML) | Experimental | Subjects with Advanced primary AML or MDS secondary to AML or AML-MR. Receives: Drug: STI-8591 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
Measured: Up to 3 years.
Secondary outcomes (12)
Assessment of the AUC of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:AUC(area under the concentration-time curve)
Measured: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessment of the Tmax of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:Tmax (time to peak)
Measured: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessment of the Cmax of STI-8591 and its major metabolites (if any).
Assessment of the pharmacokinetic profile of STI-8591 and its major metabolites (if any) in advanced AML:Cmax(peak concentration)
Measured: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Percentage change in FLT3 plasma inhibitory activity (PIA) relative to baseline
Assessment of the percentage of biomarker changes relative to baseline for STI-8591 in advanced AML
Measured: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessing the CRc of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:CRc, defined as CR, CRh and CRi as judged according to ELN2022 criteria.
Measured: Through study completion, an average of 2 years.
Assessing the CR rate of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:CR rate, defined as the CR rate judged according to ELN 2022 criteria.
Measured: Through study completion, an average of 2 years.
Assessing the objective remission rate ORR (CRc + PR + morphologic leukemia-free status [MLFS]) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:ORR, defined as CR, CRh, CRi, MLFS and PR as judged by ELN2022 criteria.
Measured: Through study completion, an average of 2 years.
Assessing the duration of remission (DOR) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:DoR, defined as the time between the subject's first achievement of ORR and the first detection of recurrent disease, treatment failure, or death from any cause, whichever occurs first.
Measured: Through study completion, an average of 2 years.
Assessing the event-free survival (EFS) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:EFS, defined as the time from the start of the subject's enrollment to the occurrence of any event (treatment failure/relapse after CR, CRh or CRi/permanent termination of treatment for any reason/death from any cause), whichever occurs first.
Measured: Through study completion, an average of 2 years.
Assessing the progression-free survival (PFS) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:PFS, defined as the time between the subject's first study treatment and the onset of treatment failure or death from any cause, whichever occurs first.
Measured: Through study completion, an average of 2 years.
Assessing the leukemia-free survival (LFS) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:LFS, defined as the time between the first attainment of CRc and the first detection of recurrent disease or death from any cause, whichever occurs first.
Measured: Through study completion, an average of 2 years.
Assessing the overall survival (OS) of STI-8591 in advanced AML.
Assessing the initial effectiveness of STI-8591 in advanced AML:OS, defined as the time between the subject's first study treatment and death from any cause.
Measured: Through study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start8 Dec 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies 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
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947344
- Sponsor's protocol ID
- FLT3-AML-101CN
- Status last verified
- Mar 2025
- First submitted
- 25 Jun 2023
- Last updated
- 17 Mar 2025
- 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 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Dose Escalation and Dose Expansion Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)
- ClinicalTrials.gov ID
- NCT05947344
- Acronym / sponsor ID
- FLT3-AML-101CN
- Conditions
- AML, Adult
- Keywords
- FLT3 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Zhejiang ACEA Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Jul 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.
This is a first-in-human, dose-escalation and dose-expansion Phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of STI-8591 in subjects with advanced AML who have signed an informed consent form (ICF) and have been screened for enrollment in this study.
- Dose escalation phase: rapid titration and conventional 3+3 test design were used to evaluate the safety, dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and PK characteristics of STI-8591.
- Dose Expansion Phase: Evaluate the safety, preliminary efficacy and determine the recommended phase II dose (RP2D) of STI-8591 for the treatment of subjects with advanced AML under the conditions of reaching the expanded dose.
Detailed description
Dose escalation phase:Based on the preclinical trial data and with reference to the modified Fibonacci method, the dose escalation ratios are 100%, 100%, 50% and 6.7%, and the initial 5 dose groups for STI-8591 dose escalation are 40, 80, 160, 240 and 280 mg/day, respectively. Screened subjects will be entered into the 5 dose groups in order of succession from lowest to highest dose.This test dose increment will be performed using the rapid titration method and the traditional 3+3 test design.
Dose expansion phase:During dose escalation, for dose groups (except for ≥2 DLT dose groups) when the following dose signals suggesting initial efficacy are present.
- CR, CRh or CRi in ≥1 subject in either dose group.2) Median decrease in FLT3 phosphorylation was ≥90% in ≥3 subjects in either dose group.The SRC will decide whether to initiate an extension study for that dose group and its subsequent dose groups at the same time as the dose escalation to the next dose group. Subjects in the dose escalation phase will be administered BID every 28 days in 1 cycle, with ≥8h between doses, fasting for at least 2 hours before and at least 1 hour after dosing with approximately 240mL of water (subject to adjustment based on data results from the dose escalation phase) . If initiation was determined, the dose group identified for initiation and its subsequent dose group extension studies were further enrolled in 14 to 17 cases [a total of 20 cases in each dose group, with FLT3 mutation-positive (FLT3 internal tandem repeat (ITD) and/or FLT3 tyrosine kinase structural domain (TKD) mutation-positive subjects enrolled in at least 10 cases] to further define the final RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STI-8591 in Advanced Acute Myeloid Leukemia (AML) | Experimental | Drug: STI-8591Subjects with Advanced primary AML or MDS secondary to AML or AML-MR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- To be enrolled in this study, subjects must meet all of the following inclusion criteria.
- Voluntary signing of ICF.
- Age ≥ 18 years old.
- Expected survival >12 weeks.
- Dose escalation component: Advanced primary AML or myelodysplastic neoplasm (MDS) secondary to AML or MDS/myeloproliferative neoplasm (MPN)-associated AML (AML-MR) diagnosed by 2022 WHO AML typing and with diagnostic criteria that have failed standard therapy or are intolerant of standard therapy may be considered for inclusion in this component of the study. Dose extension section: Advanced primary AML or MDS secondary to AML or AML-MR diagnosed according to the 2022 WHO AML typing and associated diagnostic criteria, who have failed or are intolerant to standard therapy, or who are unable to access standard therapy for various reasons, may only be considered for inclusion in this part of the study.
Key exclusion criteria (31 listed)
- To be enrolled in this study, subjects must not meet any of the following exclusion criteria.
- Known hypersensitivity to any component of the study drug formulation.
- Subjects were diagnosed with acute promyelocytic leukemia (APL).
- Subjects have BCR-ABL positive leukemia (chronic myelogenous leukemia acute).
- Subjects developed secondary AML after previous antitumor therapy for other tumors (except MDS, MDS/MPN).
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 |
|---|---|---|
| STI-8591Also: STI-8591 aloneFour dosing cohorts will be evaluated in the dose escalation phase: 20mg, 40mg, 60mg and 80mg. Expansion is planned in two dose groups of 40mg and 60mg. | Drug | STI-8591 in Advanced Acute Myeloid Leukemia (AML) |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Up to 3 years.
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5)
12 secondary outcomes
Assessment of the AUC of STI-8591 and its major metabolites (if any).
Time frame: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessment of the Tmax of STI-8591 and its major metabolites (if any).
Time frame: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessment of the Cmax of STI-8591 and its major metabolites (if any).
Time frame: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Percentage change in FLT3 plasma inhibitory activity (PIA) relative to baseline
Time frame: At the end of Cycle 1 and the first day of Cycle 2 (each cycle is 30 days) .
Assessing the CRc of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the CR rate of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the objective remission rate ORR (CRc + PR + morphologic leukemia-free status [MLFS]) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the duration of remission (DOR) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the event-free survival (EFS) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the progression-free survival (PFS) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the leukemia-free survival (LFS) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Assessing the overall survival (OS) of STI-8591 in advanced AML.
Time frame: Through study completion, an average of 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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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.
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 STI-8591 in people with AML, Adult, run by Zhejiang ACEA Pharmaceutical 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 16 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 17 Mar 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Jin, Doctor (0571-87236896, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: Up to 3 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 17 Mar 2025.