NSCLCPhase 1NCT06050980
Phase I Study of HSK40118 in NSCLC Patients With EGFR Mutation
A Phase 1 study testing HSK40118 in people with NSCLC, run by Haisco Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial summary
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- HSK40118
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 12 sitesChina
- Study dates
- 27 Mar 2023to 7 Jun 2027
- 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
- Age ≥ 18 years, Male and female patients, at time of signing informed consent form (ICF).
- ECOG=0-1, with no deterioration in 2 weeks before first dose of HSK40118.
- Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
- Patients will provide blood or tumor sample according to their own willingness.
- Patients in Phase Ia and Ib will fulfill the different criteria of the following:
- Phase Ia(Part A): Previous treatment with at least one EGFR-TKI, including 1st, 2nd and 3rd-generation EGFR-TKI; Phase Ia(Part B)/Phase Ib: Previous treatment with 3rd-generation EGFR-TKI.
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- tumour lesions/lymph nodes: Phase Ia(Part A): Patients should have at least one assessable tumour lesions/malignant lymph nodes; Phase Ia(Part B) /Phase Ib: Patients should have at least one measurable tumour lesions/malignant lymph nodes.
- Life expectancy ≥ 3 months.
- Adequate hematologic and organ function per protocol.
- Women of childbearing potential (WOCBP) and fertile males with WOCBP partners must use highly effective contraception per protocol throughout and after 90 days of the last dose of the study.
Who cannot join
- malignant tumor within 5 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
- Unstable spinal cord compression or brain metastases per protocol.
- Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
- Prior treatment with 4th-generation EGFR-TKIs(TKI for 3th-generation resistance).
- Treatment with any of the following:
- Prior treatment with an EGFR-TKI or other small-molecule anti-tumor drug within 7 days or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter; Prior treatment with chemotherapy, palliative radiotherapy, or Herbal therapy within 2 weeks or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter; Prior treatment with radiotherapy, immunotherapy/biotherapy therapy, or other pharmaceutical clinical trial within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK40118, whichever is shorter.
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- Treatment with inhibitors for P-glycoprotein (P-gp) within 7 days prior to the first dose of HSK40118.
- Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.
- Any disease which would cause chronic diarrhea, eg. Crohn's disease, or irritable bowel syndrome.
- Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.
- Any severe disease of respiratory system, eg. interstitial lung disease, radiation pneumonitis, drug-induced pneumonitis, or uncontrolled asthma.
- Patient who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)/470(female) msec; any clinically significant arrhythmia; left ventricular ejection fraction < 50%; myocardial infarction, unstable angina, or class III/IV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK40118.
- Any thromboembolic events within 6 months prior to the first dose of HSK40118; any familial or aquired thrombophilia.
- Active bleeding at screening, history of visceral hemorrhage within 3 months prior to the first dose of HSK40118, or visceral bleeding tendency within 6 months prior to the first dose of HSK40118.
- Patient who is undergoing, or receiving long-term(> 6 months) anticoagulant/antiplatelet therapy; receiving drugs affecting coagulation function 1 week prior to the first dose of HSK40118.
- INR, APTT > 1.5xULN, or any bleeding tendency or coagulopathy at screening.
- Uncontroled hypertension(systolic pressure ≥160mmHg, or diastolic pressure ≥100mmHg).
- Any unstable systemic disease, eg. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
- Any disease of the eyes > CTCAE v5.0 Grade 1.
- Autologous transplantation surgery within 3 months prior to the first dose of HSK40118; Allogeneic transplantation, or stem-cell Transplant surgery within 6 months prior to the first dose of HSK40118; Major surgery or significant traumatic injury occurring within 4 weeks prior to the first dose of HSK40118.
- Patients with HIV, HBV or HCV infection.
- Patients with active syphilis infection.
- Patients who have an uncontroled systematic infection, eg. fungal, bacterial, or virus infection.
- Patients who would interfere with cooperation or outcome-assessment of the trial.
- Allergic to any HSK40118 active constituent or ingredients.
- (Child-bearing period women only)Patients testing positive for pregnancy, or during lactation.
- Any other circumstances that would, in the investigator's judgment, prevent the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Ning Li, 010-87788713, lining@cicams.ac.cn
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Lin Wu, 13170419973, wulin-calf@vip.163.com
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
Yongsheng Li, 17784310187, yongshengli2005@163.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Gen Lin, 13313786157, lingen197505@163.com
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081
Yan Yu, 13904505825, gpyuyan@163.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Yuping Sun, 13370582181, 13370582181@163.com
- Recruiting
First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Zhiye Zhang, 13783100985, 13783100985@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530000
Qitao Yu, 13367816089, yqt178@163.com
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Caicun Zhou, 13301825532, caicunzhoudr@163.com
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110002
Xiujuan Qu, 13604031355, cmuquxiujuan@163.com
- Recruiting
Taizhou hospital of Zhejiang Province
Taizhou, Zhejiang, 318050
Dongqing Lv, 13867622009, lvdq@enzemed.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Qiming Wang, 13783590691, qimingwang1006@126.com
About this study
Official title: A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK40118 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Read the detailed description
Phase Ia will contain two part: Dose Escalation Part(Part A) and Extension Part(Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK40118. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia.
Phase Ib no less than 130 subjects will be enrolled in each expansion cohort, cohort A will be enrolled 30-50 subjects, cohort B will be enrolled no less than 100 subjects.
- Conditions
- NSCLC
- Being tested
- HSK40118
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK40118Drug
Oral administration, QD
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia(Part A): HSK40118 as monotherapy | Experimental | Phase 1a(Part A): dose escalation of HSK40118 as monotherapy at various dose levels Receives: Drug: HSK40118 |
| Phase Ia(Part B): HSK40118 as monotherapy | Experimental | Phase 1a(Part B): dose extention of HSK40118 as monotherapy at certain dose levels Receives: Drug: HSK40118 |
| Phase Ib: HSK40118 as monotherapy | Experimental | Phase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1 in patients with previous treatment with 3rd-generation EGFR-TKI Receives: Drug: HSK40118 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
MTD determination: dose limiting toxicity (DLT) rate
Measured: Up to approximately 52 months
DLTs
Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1
Measured: Up to approximately 52 months
AEs
Rate and severity of adverse events of HSK40118 as monotherapy
Measured: Up to approximately 52 months
Eastern Cooperative Oncology Group Performance Status Scale(ECOG PS)
Change of the grade as a part of HSK40118 safety data. The functional status of patients will be assessed by the ECOG PS, which is described as a scale including grade 0(fully active) to grade 5(dead).
Measured: Up to approximately 52 months
Secondary outcomes (15)
Overall response rate(ORR)
ORR, defined as the proportion of patients who experience a best response of confirmed CR or PR according to RECIST 1.1
Measured: Up to approximately 52 months
Disease control rate (DCR)
DCR, defined as the proportion of patients who experience a best response of CR, PR, or stable disease (SD) according to RECIST 1.1
Measured: Up to approximately 52 months
Duration of response (DOR)
DOR, defined as the time from first documented response of complete response (CR) or partial response (PR) to the date of first documented progressive disease or death due to any cause, whichever occurs first
Measured: Up to approximately 52 months
Progression free survival (PFS)
PFS, defined as the time from the first dose of HSK40118 until the date of first documented progressive disease or death due to any cause, whichever occurs first
Measured: Up to approximately 52 months
Overall survival (OS)
OS, defined as the time from the first dose of HSK40118 until the date of death due to any cause
Measured: Up to approximately 52 months
AUC of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. AUC is the definite integral of a curve that describes the variation of a drug concentration in blood plasma as a function of time. AUC reflects the actual body exposure to drug after single dosing and at steady state after multiple dosing.
Measured: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmax of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Cmax is the maximum (or peak) serum concentration that the drug achieves in blood after the drug has been administered.
Measured: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmin of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Cmin is the minimum (or trough) serum concentration that the drug achieves in blood at steady state after multiple dosing.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Tmax of HSK40118
Pharmacokinetics (PK) parameter of HSK40118. Tmax is defined as the time of maximum concentration of the drug in blood observed after single dosing and at steady state after multiple dosing.
Measured: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Terminal half life(t1/2) after single dosing of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of the terminal half-life after single dosing.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
CL/F of HSK40118
Rate and extent of absorption of HSK40118 by assessment of apparent clearance following oral administration.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Vd/F of HSK40118
Rate and extent of absorption of HSK40118 by assessment of the apprarent volume of distribution.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
λz of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of first-order rate constant associated with the terminal (log-linear) portion of the curve.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
MRT(Mean residence time) of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of mean residence time, which meas AUMC(Area under the moment curve)/AUC(Area under the curve) of drug concentration in blood plasma.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Cav,ss(average concentration at steady state) of HSK40118
Pharmacokinetics (PK) parameter of HSK40118 by assessment of average concentration at steady state after multiple dosing.
Measured: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start27 Mar 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion7 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Haisco 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050980
- Sponsor's protocol ID
- HSK40118-101
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2023
- Last updated
- 22 Sep 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 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of HSK40118 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLC
- ClinicalTrials.gov ID
- NCT06050980
- Acronym / sponsor ID
- HSK40118-101
- Conditions
- NSCLC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 7 Jun 2027 (estimated)
- First posted
- 22 Sep 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 phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK40118 when given orally in patients with active EGFR mutation locally advanced or metastatic non-small cell lung cancer (NSCLC).
The study will contain two phase: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase.
Detailed description
Phase Ia will contain two part: Dose Escalation Part(Part A) and Extension Part(Part B). Part A based on the "3+3" design for dose escalation and safety evaluation requirements. Patient cohorts at selected doses may be extended to further investigate the tolerability, PK and PD of HSK40118. The number of patients to be enrolled will be up to 10 subjects in each Part B cohort. Approximately 30-70 subjects will be enrolled in Phase Ia.
Phase Ib no less than 130 subjects will be enrolled in each expansion cohort, cohort A will be enrolled 30-50 subjects, cohort B will be enrolled no less than 100 subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia(Part A): HSK40118 as monotherapy | Experimental | Drug: HSK40118Phase 1a(Part A): dose escalation of HSK40118 as monotherapy at various dose levels |
| Phase Ia(Part B): HSK40118 as monotherapy | Experimental | Drug: HSK40118Phase 1a(Part B): dose extention of HSK40118 as monotherapy at certain dose levels |
| Phase Ib: HSK40118 as monotherapy | Experimental | Drug: HSK40118Phase 1b: dose expansion for HSK40118 as monotherapy at a dose determined during Phase 1 in patients with previous treatment with 3rd-generation EGFR-TKI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, Male and female patients, at time of signing informed consent form (ICF).
- ECOG=0-1, with no deterioration in 2 weeks before first dose of HSK40118.
- Histological or cytological confirmed diagnosis of unresectable locally advanced or metastatic NSCLC.
- Patients will provide blood or tumor sample according to their own willingness.
- Patients in Phase Ia and Ib will fulfill the different criteria of the following:
Key exclusion criteria (27 listed)
- malignant tumor within 5 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
- Unstable spinal cord compression or brain metastases per protocol.
- Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
- Prior treatment with 4th-generation EGFR-TKIs(TKI for 3th-generation resistance).
- Treatment with any of the following:
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 |
|---|---|---|
| HSK40118Oral administration, QD | Drug | Phase Ia(Part A): HSK40118 as monotherapy, Phase Ia(Part B): HSK40118 as monotherapy, Phase Ib: HSK40118 as monotherapy |
Primary outcome
MTD
Time frame: Up to approximately 52 months
MTD determination: dose limiting toxicity (DLT) rate
DLTs
Time frame: Up to approximately 52 months
Incidence of dose-limiting toxicities (DLTs) at Cycle 0 and Cycle1
AEs
Time frame: Up to approximately 52 months
Rate and severity of adverse events of HSK40118 as monotherapy
Eastern Cooperative Oncology Group Performance Status Scale(ECOG PS)
Time frame: Up to approximately 52 months
Change of the grade as a part of HSK40118 safety data. The functional status of patients will be assessed by the ECOG PS, which is described as a scale including grade 0(fully active) to grade 5(dead).
15 secondary outcomes
Overall response rate(ORR)
Time frame: Up to approximately 52 months
Disease control rate (DCR)
Time frame: Up to approximately 52 months
Duration of response (DOR)
Time frame: Up to approximately 52 months
Progression free survival (PFS)
Time frame: Up to approximately 52 months
Overall survival (OS)
Time frame: Up to approximately 52 months
AUC of HSK40118
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmax of HSK40118
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Cmin of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Tmax of HSK40118
Time frame: Blood samples will be collected on 6 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3, cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
Terminal half life(t1/2) after single dosing of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
CL/F of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Vd/F of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
λz of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
MRT(Mean residence time) of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 0 day 1, cycle 0 day 2, cycle 0 day 3.
Cav,ss(average concentration at steady state) of HSK40118
Time frame: Blood samples will be collected on 3 occasions for each patient throughout study: cycle 1 day 1, cycle 1 day 8 and cycle 1 day 15.
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 22 Sep 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK40118 in people with NSCLC, run by Haisco Pharmaceutical Group Co., Ltd. at 12 sites 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 10 inclusion and 27 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 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 Fangqiong Li (+8602867258840, lifangq@haisco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: Up to approximately 52 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.