EGFR Mutation Positive Advanced Non-Small Cell Lung CancerPhase 1/2NCT06631989
A Study to Assess the Efficacy and Safety of WSD0922-FU in Patients With EGFRm+ Advanced Non-small Cell Lung Cancer
A Phase 1/2 study testing WSD0922-FU in people with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer, run by Wayshine Biopharm, Inc. at 12 sites in China.
Trial summary
This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer
- What is being tested?
- WSD0922-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 12 sitesChina
- Study dates
- 4 Sep 2024to 31 Dec 2027
- Phase
- Phase 1/2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old (including the threshold value), gender is not limited;
- Locally advanced or metastatic NSCLC confirmed by pathology;
- Patients who have been genetically tested to carry EGFR sensitive mutations;
- Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;
- Must have a minimum life expectancy of >= 3 months;
- At least one measurable tumor lesion according to RECIST version 1.1; Previous radiotherapy-treated lesions cannot be used as target lesions unless imaging studies show clear progression of the lesions.
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- Physical Status (ECOG PS) score was 0-1;
- Have full organ function;
- Eligible patients (male and female) who are fertile must agree to use a reliable contraceptive method ;
- Subjects are required to give informed consent to this study before the experiment and sign a written informed consent voluntarily.
Who cannot join
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
- Have previously received more than one EGFR-TKI inhibitor;
- Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
- Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
- Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
- Known active brain metastasis or progression evidence.
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- Other primary malignant tumors within 2 years before the first administration of the study drug.
- Adverse reactions from previous anti-tumor treatments have not recovered to NCI-CTCAE v5.0 grade ≤1 (except for toxicities judged by the researcher to have no safety risks, such as hair loss, grade 2 peripheral neurotoxicity, and stable thyroid function after hormone replacement therapy).
- Skin/pressure ulcers, chronic leg ulcers, known active gastric ulcers, or non-healing wounds.
- History of severe allergies, or allergies to any active or inactive ingredients of the study drug;
- Severe infections requiring intravenous antibiotic infusion or hospitalization at the time of screening; or uncontrollable active infections within 4 weeks before administration;
- Known active or suspected autoimmune diseases; or known active ocular diseases (such as active wet age-related macular degeneration, diabetic retinopathy with macular edema);
- Human immunodeficiency virus (HIV) (HIV1/2 antibody) positive, syphilis spirochete antibody positive .
- Patients with interstitial lung disease.
- History of severe cardiovascular diseases.
- Unable to orally swallow medication, or there is a condition that significantly affects gastrointestinal absorption as judged by the researcher;
- Clinical intervention is required for pleural effusion, ascites (excluding subjects who do not need drainage and have been stable for more than 2 weeks after drainage).
- Known alcohol or drug dependence.
- Mental disorders or poor compliance;
- Pregnant or lactating women;
- The investigator believes that the subject has other reasons that make them unsuitable for participating in this clinical study.
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
Principal Investigator, 86-10-67781331, jie_969@163.com
- Recruiting
Sichuan Provincial Cancer Hospital
Chengdu, Sichuan, 610041
Principal Investigator, 86-28-85420305, dr.lijuan@hotmail.com
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510062
Principal Investigator, 86-20-87331952, tangkejing@163.com
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310006
Principal Investigator, 86 -571-87236697, zjyalcyj@sina.com
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230031
Principal Investigator, 86-551-65327766, yueyinpan1965@126.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Principal Investigator, 86-531-87984777, xinglg@medmail.com.cn
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Principal Investigator, 86-21-62821990, eddiedong8@hotmail.com
- Recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200123
Anwen Xiong, MD
Caicun Zhou, MD
- Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Principal Investigator, 02165115006, fywu@163.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Principal Investigator, 86-576-85112241, lvdq855@126.com
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300202
Principal Investigator, 02223353454, dingzhih72@163.com
- Recruiting
He'nan Cancer Hospital
Zhengzhou, Henan, 450000
Principal Investigator, 86-371-65861505, 13938252350@163.com
About this study
Official title: A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer
This study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .
Read the detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance.
- Being tested
- WSD0922-FU
- Keywords
- NSCLC, EGFR, C797S, BM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WSD0922-FUDrug
Also called WSD0922
Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples
Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI
Drug: WSD0922-FU Given PO
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation (WSD0922-FU) | Experimental | Patients receive WSD0922-FU PO QD on C0D1 to C0D3, then BID on C1D1 to C1D21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. Receives: Drug: WSD0922-FU |
| Dose expansion (WSD0922-FU) | Experimental | Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. Receives: Drug: WSD0922-FU |
| Dose extension (WSD0922-FU) | Experimental | Patients receive WSD0922-FU PO BID on C1D1 to C1D21 using RP2D. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. Receives: Drug: WSD0922-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR by IRC
proportion of patients with a best overall response of complete response or partial response
Measured: every 6 weeks, up to 1 year
PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC
Safety (incidence and severity of adverse events [AE])
Measured: 8 months
PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC
Incidence and quantity of dose-limiting toxicity (DLT)
Measured: 8 months
PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 8 months
PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC
Recommended Phase II Dose (RP2D)
Measured: 8 months
Secondary outcomes (27)
PK exposure parameter: Maximum Plasma Concentration (Cmax)
Maximum Plasma Concentration (Cmax)
Measured: 12 months
PK exposure parameter: Time To Maximum Plasma Concentration (Tmax)
Time To Maximum Plasma Concentration (Tmax)
Measured: 12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)
Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)
Measured: 12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)
Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)
Measured: 12 months
PK exposure parameter: Terminal Elimination Half-Life (t½)
Terminal Elimination Half-Life (t½)
Measured: 12 months
PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz)
Apparent Terminal Elimination Rate Constant (λz)
Measured: 12 months
PK exposure parameter: Apparent Clearance (CL)
Apparent Clearance (CL)
Measured: 12 months
PK exposure parameter: Apparent volume of distribution (Vd)
Apparent volume of distribution (Vd)
Measured: 12 months
PK exposure parameter: Mean Residence Time (MRT)
Mean Residence Time (MRT)
Measured: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss）
Area Under the Steady-State Concentration-Time Curve（AUCss）
Measured: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）
Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）
Measured: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）
Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）
Measured: 12 months
Steady state pharmacokinetic parameter: Average Steady-State Concentration（Cav）
Average Steady-State Concentration（Cav）
Measured: 12 months
Steady state pharmacokinetic parameter: Steady-State Clearance（CLss）
Steady-State Clearance（CLss）
Measured: 12 months
PK exposure parameter :Maximum Steady-State Concentration（Cmax,ss）
Maximum Steady-State Concentration（Cmax,ss）
Measured: 12 months
PK exposure parameter : Minimum Steady-State Concentration（Cmin,ss）
Minimum Steady-State Concentration（Cmin,ss）
Measured: 12 months
PK exposure parameter : Trough Concentration（Ctrough）
Trough Concentration（Ctrough）
Measured: 12 months
PK exposure parameter : Fluctuation Degree（DF）
Fluctuation Degree（DF）
Measured: 12 months
PK exposure parameter : Accumulation Ratio（Ra）
Accumulation Ratio（Ra）
Measured: 12 months
PK exposure parameter : Time to Maximum Concentration at Steady State（Tmax,ss）
Time to Maximum Concentration at Steady State（Tmax,ss）
Measured: 12 months
PK exposure parameter : Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）
Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）
Measured: 12 months
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer
Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs)
Measured: 12 months
ORR by investigators
proportion of patients with a best overall response of complete response or partial response
Measured: every 6 week, up to 12 months
Disease Control Rate (DCR)
the percentage of patients who have a best overall response of CR or PR or SD
Measured: every 6 weeks, up to12 months
Duration of Response (DoR)
proportion of patients with the time from the date of first documented response until the date of documented progression or death in the absence of disease progression
Measured: every 6 weeks, up to 12 months
PFS
proportion of patients with the time from randomization until the date of objective disease progression or death
Measured: every 6 weeks, up to 12 months
OS
proportion of patients with the time from randomization until the date of objective disease progression or death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start4 Sep 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EGFR Mutation Positive Advanced Non-Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part A (Dose escalation and expansion study) ; Part B (single-arm extension study).
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayshine Biopharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caicun Zhou, MD, Principal investigator, Shanghai East Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631989
- Sponsor's protocol ID
- WSD0922-102
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2024
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Multicenter, Open Label, Single-arm Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of WSD0922-FU in the Treatment of Advanced Non-small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06631989
- Acronym / sponsor ID
- WSD0922-102
- Keywords
- NSCLC, EGFR, C797S, BM
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wayshine Biopharm, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2024 (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 study is a multicenter, open label, single-arm phase I/II clinical trial of WSD0922-FU for patients with locally advanced or metastatic non-small cell lung cancer whose disease has progressed with thrid-generation EGFR-TKI .
Detailed description
WSD0922-FU is a potent reversible inhibitor of both the single EGFRm+ and dual EGFRm+/C797S+ receptor forms of EGFR with selectivity margin over wild-type EGFR. This study aims to explore the safety, tolerability, pharmacokinetic characteristics and efficacy of WSD0922-FU in patients with non-small cell lung cancer (NSCLC) with C797S mutation after first-line third-generation EGFR-TKI resistance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Part A (Dose escalation and expansion study) ; Part B (single-arm extension study).
| Arm | Type | Receives |
|---|---|---|
| Dose escalation (WSD0922-FU) | Experimental | Drug: WSD0922-FUPatients receive WSD0922-FU PO QD on C0D1 to C0D3, then BID on C1D1 to C1D21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. |
| Dose expansion (WSD0922-FU) | Experimental | Drug: WSD0922-FUPatients receive WSD0922-FU PO BID on C1D1 to C1D21 using dosage selected from Dose escalation. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. |
| Dose extension (WSD0922-FU) | Experimental | Drug: WSD0922-FUPatients receive WSD0922-FU PO BID on C1D1 to C1D21 using RP2D. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and blood sample collection on study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-75 years old (including the threshold value), gender is not limited;
- Locally advanced or metastatic NSCLC confirmed by pathology;
- Patients who have been genetically tested to carry EGFR sensitive mutations;
- Blood samples must be provided for testing and must be taken during or after disease progression following the last EGFR TKI inhibitor treatment;
- Must have a minimum life expectancy of >= 3 months;
Key exclusion criteria (21 listed)
- Received chemotherapy, radiotherapy, biological therapy, targeted therapy, endocrine therapy, immunotherapy, or other anti-tumor drug treatments within 4 weeks before the first administration of the study drug.
- Have previously received more than one EGFR-TKI inhibitor;
- Received other unlisted clinical study drugs or treatments within 4 weeks before the first administration.
- Received major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks before the first administration, or require elective surgery during the trial period.
- Used strong CYP3A4 inhibitors or strong CYP3A4 inducers within 7 days before the first use of the study drug.
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 |
|---|---|---|
| WSD0922-FUAlso: WSD0922Procedure: Biospecimen Collection - blood samples Undergo collection of blood samples Procedure: Computed Tomography and/or Magnetic Resonance Imaging Undergo CT and/or MRI Drug: WSD0922-FU Given PO | Drug | Dose escalation (WSD0922-FU), Dose expansion (WSD0922-FU), Dose extension (WSD0922-FU) |
Primary outcome
ORR by IRC
Time frame: every 6 weeks, up to 1 year
proportion of patients with a best overall response of complete response or partial response
PartA: To evaluate the safety of WSD0922-FU in patients with NSCLC
Time frame: 8 months
Safety (incidence and severity of adverse events [AE])
PartA: To evaluate the tolerability of WSD0922-FU in patients with NSCLC
Time frame: 8 months
Incidence and quantity of dose-limiting toxicity (DLT)
PartA: To evaluate the Maximum Tolerated Dose (MTD) of WSD0922-FU in patients with NSCLC
Time frame: 8 months
Incidence of Dose-Limiting Toxicities (DLTs)
PartA: Recommended Phase II Dose (RP2D) of WSD0922-FU in patients with NSCLC
Time frame: 8 months
Recommended Phase II Dose (RP2D)
27 secondary outcomes
PK exposure parameter: Maximum Plasma Concentration (Cmax)
Time frame: 12 months
PK exposure parameter: Time To Maximum Plasma Concentration (Tmax)
Time frame: 12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Time With Last Measurable Concentration (AUC0-t)
Time frame: 12 months
PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Infinity (AUC0-∞)
Time frame: 12 months
PK exposure parameter: Terminal Elimination Half-Life (t½)
Time frame: 12 months
PK exposure parameter: Apparent Terminal Elimination Rate Constant (λz)
Time frame: 12 months
PK exposure parameter: Apparent Clearance (CL)
Time frame: 12 months
PK exposure parameter: Apparent volume of distribution (Vd)
Time frame: 12 months
PK exposure parameter: Mean Residence Time (MRT)
Time frame: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve（AUCss）
Time frame: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Infinity（AUC0-∞,ss）
Time frame: 12 months
Steady state pharmacokinetic parameter: Area Under the Steady-State Concentration-Time Curve from 0 to Time t （AUC0-t,ss）
Time frame: 12 months
Steady state pharmacokinetic parameter: Average Steady-State Concentration（Cav）
Time frame: 12 months
Steady state pharmacokinetic parameter: Steady-State Clearance（CLss）
Time frame: 12 months
PK exposure parameter :Maximum Steady-State Concentration（Cmax,ss）
Time frame: 12 months
PK exposure parameter : Minimum Steady-State Concentration（Cmin,ss）
Time frame: 12 months
PK exposure parameter : Trough Concentration（Ctrough）
Time frame: 12 months
PK exposure parameter : Fluctuation Degree（DF）
Time frame: 12 months
PK exposure parameter : Accumulation Ratio（Ra）
Time frame: 12 months
PK exposure parameter : Time to Maximum Concentration at Steady State（Tmax,ss）
Time frame: 12 months
PK exposure parameter : Volume of Distribution Calculated from the Terminal Elimination Phase（Vz）
Time frame: 12 months
To evaluate the safety of WSD0922-FU in patients with advanced non-small cell lung cancer
Time frame: 12 months
ORR by investigators
Time frame: every 6 week, up to 12 months
Disease Control Rate (DCR)
Time frame: every 6 weeks, up to12 months
Duration of Response (DoR)
Time frame: every 6 weeks, up to 12 months
PFS
Time frame: every 6 weeks, up to 12 months
OS
Time frame: 24 months
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 29 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Caicun Zhou, MD principal investigator
Shanghai East Hospital
12 sites 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 WSD0922-FU in people with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer, run by Wayshine Biopharm, Inc. 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 21 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 29 Aug 2025. 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 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?
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 lily liu, MD (+8613818880308, lily.liu@wayshinebiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR by IRC (time frame: every 6 weeks, up to 1 year). 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 29 Aug 2025.