NSCLC (Non-small Cell Lung Cancer)Phase 1/2NCT07063329

Phase I/II Study of PLB1004 Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive

A Phase 1/2 study testing PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy and RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy in people with NSCLC (Non-small Cell Lung Cancer), run by Avistone Pharmaceutical（Ningbo）Co., LTD. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: NSCLC (Non-small Cell Lung Cancer)
What is being tested?: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy and RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 108 participants
Where: 2 sitesChina
Study dates: 22 Aug 2025to 8 Jul 2028
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

1. Phase Ib Dose-escalation Part : Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of the AJCC lung cancer staging criteria) who have disease progression or intolerance after previous systemic treatment. Specific treatment requirements are as follows:
Patients with EGFR sensitive mutations: They must have received EGFR-TKI treatment. If only first/second-generation EGFR-TKIs were used, T790M negativity must be confirmed.
Patients with other EGFR mutations such as EGFR exon 20 insertion: They must have received platinum-based chemotherapy.
Phase Ib Dose-expansion part and Cohort 1 of Phase II: Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment or have received systemic treatment.
Cohort 2 of Phase II: Patients with histologically confirmed resectable stage II-III NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment; among them, N2 is defined as single-station mediastinal lymph node non-bulky metastasis (lymph node short diameter <2 cm) confirmed by imaging and pathology, with expected complete resection.
2. Previous tumor tissue or pleural effusion or blood sample confirmed positive for EGFR mutation.

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3. Measurable lesions at baseline according to RECIST 1.1 criteria.
4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
5. Estimated life expectancy is more than 12 weeks.
6. It has been medically evaluated and determined that the organ functions are good (within 7 days before the first study drug administration), including:
hematological : absolute neutrophil count (ANC) ≥ 1.5 × 109/L, hemoglobin ≥ 90 g/L, platelets ≥ 100 × 109/L. Platelet transfusion is not allowed within 3 days before testing, red blood cell transfusion is not allowed within 14 days before testing, and hematopoietic growth factor therapy is not allowed within 7 days before testing (pegylated granulocyte colony-stimulating factor [G-CSF] or erythropoietin [EPO] is within 14 days before testing).
liver function: serum TBIL ≤ 1.5×ULN (in patients with known Gilbert syndrome, TBIL ≤ 3×ULN and direct bilirubin [DBIL] ≤ 1.5×ULN), serum ALT/AST ≤ 2.5×ULN (for patients with confirmed liver metastases, ≤ 5.0×ULN).
Renal function: Creatinine clearance ≥ 50 mL/min.
coagulation function, defined as (including during anticoagulant therapy): prothrombin time (PT)<1.5 × ULN, activated partial thromboplastin time (APTT)<1.5 × ULN. If the subject is receiving anticoagulant therapy, they must receive a stable dose of anticoagulant at least one month prior to the first study administration.
7. For cohort 2 of phase II: According to the surgeon's assessment, the total lung function can tolerate the planned pulmonary resection surgery.
8. Female patients must use effective contraceptive measures during the study and for 90 days after the end of study treatment, and must not breastfeed.Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to the first dose.

Who cannot join

1. Participated in other therapeutic clinical trials within 28 days prior to the first dose。
2. Patients underwent major organ surgery within 4 weeks prior to the first dose.or is expected to undergo major surgery during the study.
3. Have received lung field or whole-brain radiotherapy within 28 days before the first study drug administration, or has received palliative local radiotherapy within 14 days before the first dose。
4. Patients received antitumour traditional Chinese medicine within 1 weeks prior to the first dose，and received local anti-tumor drug therapy (such as thoracic or abdominal perfusion, etc.) within 14 days or within 5 half-lives (whichever is shorter)。
5. Patients with malignancies other than tumors treated in this study (except: malignancies that are cured and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type).
6. Adverse effects of previous anti-tumor therapy have not recovered to CTCAE 5.0 grade rating of ≤ grade 1 (except for toxicity judged by the investigator be of no safety risk, such as alopecia, skin pigmentation, etc.)

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7. Have received systemic administration of potent inhibitors/inducers of CYP3A4 within 7 days prior to the first dose of treatment/randomization or are expected to receive systemic administration of these drugs during study treatment.
8. Patients have symptomatic central nervous system (CNS) metastases, meningeal metastases, or a primary CNS tumor that is associated with progressive neurological symptoms.
9. Patients have a history of severe cardiovascular disease, including but not limited to:
Mean QT interval corrected using Fridericia's formula (QTcF) from three times> 480ms at rest.
New York Heart Association (NYHA) ≥ class II heart failure or left ventricular ejection fraction (LVEF) < 50%.
10. Hypertension remains uncontrolled（systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg ） after aggressive antihypertensive therapy.
11. Patients with active uncontrolled systemic bacterial, viral, or fungal infection despite optimal treatment Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL; Hepatitis B: HCV antibody-positive , HIV antibody-positive; Active syphilis, the onset period of keratitis or ulcerative keratitis.
12. Patients are unable to swallow the drug orally, or has a condition that seriously affects gastrointestinal absorption in the judgment of the investigator.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Shun Lu M.D, Ph.D. contact

86-21-22200000

shunlu@sjtu.edu.cn

China2 sites, 2 recruiting

Shanghai Chest hospital
Shanghai
Shun Lu M.D, Ph.D, 86-21-22200000, shunlu@sjtu.edu.cn
Shun Lu M.D, Ph.D
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Qiming Wang M.D, Ph.D, +86-371-65587300, qimingwang1006@126.com
Recruiting

Other trials in China

About this study

Official title: An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC

Tyrosine Kinase Inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with EGFR-TKI, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining PLB1004 with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer.

In recent years, clinical studies on the combination of EGFR-TKI and chemotherapy have made important progress, suggesting that the combination of EGFR-TKI and chemotherapy further enhances the therapeutic benefit in EGFR-mutant positive NSCLC.

Both preclinical and clinical data indicate that PLB1004 exhibit good antitumor activity and relatively durable efficacy in NSCLC patients with EGFR mutations. They can reduce tumor burden, control tumor progression, and improve the survival benefit of patients, which is expected to provide an effective treatment option for such patients.

Read the detailed description

This study is a multicenter, open-label, dose-escalation and dose-expansion Ib/II phase study, aiming to evaluate the clinical safety, tolerability, PK and preliminary efficacy of PLB1004 combined with platinum-based doublet chemotherapy in NSCLC patients with EGFR mutations. The study consists of two parts: the phase Ib dose-escalation study and dose-expansion study, as well as the phase II clinical study. The target population of the phase Ib study is patients with confirmed locally advanced or metastatic NSCLC harboring EGFR mutations who have received or not received systemic antitumor therapy. The II phase clinical study sets up two cohorts. Cohort 1: patients with confirmed locally advanced or metastatic NSCLC harboring EGFR mutations who have received or not received systemic antitumor therapy; Cohort 2: patients with newly diagnosed resectable stage II-III NSCLC harboring EGFR mutations who have not received systemic antitumor therapy. A total of 79-108 patients are planned to be enrolled in the study, which is divided into a screening period, a treatment period and a follow-up period. During the administration of the study drug, follow-up will be conducted every 6 weeks in the first year and every 12 weeks from the second year onwards.

Conditions: NSCLC (Non-small Cell Lung Cancer)
Being tested: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy, RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
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.

PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based ChemotherapyDrug
For non-squamous NSCLC patients：Pemetrexed (500 mg/m2) plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily。 For squamous NSCLC subjects: Docetaxel（75 mg/m² ）or paclitaxel（175 mg/mg） plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily.
PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based ChemotherapyDrug
Multiple doses of PLB1004 for oral administration. Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks).
RP2D of PLB1004 oral once daily Combined with Platinum-Based ChemotherapyDrug
RP2D of PLB1004 as determined during Phase Ib . Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks）.
RP2D of PLB1004 oral once daily Combined with Platinum-Based ChemotherapyDrug
RP2D of PLB1004 as determined during Phase Ib，patients will undergo surgical treatment after 3 cycles of combination therapy with platinum-based chemotherapy. Post-surgery, they will receive an additional cycle of platinum-based chemotherapy followed by 13 cycles of maintenance therapy with PLB1004.

Study groups in NCT07063329
Study group	Role	What they receive
phase Ib Dose Escalation	Experimental	Not described Receives: Drug: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
phase Ib Dose Expansion	Experimental	Not described Receives: Drug: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
phase II Cohort1	Experimental	Not described Receives: Drug: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
phase II Cohort2	Experimental	Not described Receives: Drug: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
To evaluate the tolerability and safety of PLB1004 combined with platinum-based doublet chemotherapy in patients with epidermal growth factor receptor (EGFR) mutation positive NSCLC
Measured: 12 months
Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of PLB1004 combined with platinum-based doublet chemotherapy in patients with EGFR mutation positive NSCLC
Measured: 12 months
Phase Ib： Recommended Phase II Dose (RP2D)
To determine the recommended phase II dose (RP2D) of PLB1004 in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation positive NSCLC
Measured: 12 months
Phase Ib： Overall Response Rate (ORR）
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1
Measured: 24 months
Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D in subjects with EGFR mutation positive locally advanced or metastatic NSCLC
Objective response rate (ORR) as evaluated by the investigator according to RECIST v1.1
Measured: 36 months
Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D RP2D in newly diagnosed resectable stage II-III NSCLC subjects with EGFR mutation positive
Major pathological response (MPR) evaluated by the blinded independent pathology review committee (BIPR)
Measured: 12 months

Secondary outcomes (13)

Cmax
Single-dose PK parameters: Peak concentration (Cmax)
Measured: 12 months
DOR
Duration of response (DoR)
Measured: 36 months
PFS
Progression-Free Survival
Measured: 36 months
Tmax
Time to peak concentration (Tmax)
Measured: 12 months
(AUC0-t）
Evaluation of the area under the concentration-time curve (AUC0-t)
Measured: 12 months
T 1/2
Assessment of the first dose elimination half-life (T 1/2)
Measured: 12 months
CL/F
Assessment of apparent clearance rate of the first dose (CL/F)
Measured: 12 months
Vz/F
Apparent volume of distribution
Measured: 12 months
DCR
Disease Control Rate
Measured: 36 months
OS
Overall Survival
Measured: 36 months
EFS
Event-Free Survival
Measured: 36 months
pCR
pathological Complete Response
Measured: 36 months
DFS
Disease-Free Survival
Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 20258 Jul 2028

First posted14 Jul 2025
Study start22 Aug 2025
Primary completion8 Mar 2028 (estimated)
Study completion8 Jul 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for NSCLC (Non-small Cell Lung Cancer)Studies 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: Sequential
Masking: None (open label)
Enrolment: 108 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07063329
Sponsor's protocol ID: PLB1004 +Chemo-NSCLC-Ib/II-01
Status last verified: Oct 2026
First submitted: 24 Jun 2025
Last updated: 28 Oct 2026
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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetic of PLB1004 Capsules Combined With Platinum-based Doublet Chemotherapy in Patients With EGFR Mutation-positive NSCLC
ClinicalTrials.gov ID: NCT07063329
Acronym / sponsor ID: PLB1004 +Chemo-NSCLC-Ib/II-01
Conditions: NSCLC (Non-small Cell Lung Cancer)
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 108 participants (estimated)
Lead sponsor: Avistone Pharmaceutical（Ningbo）Co., LTD.Industry (pharma, biotech, devices)
Study start: 22 Aug 2025 (actual)
Primary completion: 8 Mar 2028 (estimated)
Study completion: 8 Jul 2028 (estimated)
First posted: 14 Jul 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
phase Ib Dose Escalation	Experimental	Drug: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
phase Ib Dose Expansion	Experimental	Drug: PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based Chemotherapy
phase II Cohort1	Experimental	Drug: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy
phase II Cohort2	Experimental	Drug: RP2D of PLB1004 oral once daily Combined with Platinum-Based Chemotherapy

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

1. Phase Ib Dose-escalation Part : Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of the AJCC lung cancer staging criteria) who have disease progression or intolerance after previous systemic treatment. Specific treatment requirements are as follows:
Phase Ib Dose-expansion part and Cohort 1 of Phase II: Patients with histologically or cytologically confirmed unresectable locally advanced (stage IIIB and IIIC) or metastatic (stage IV) NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment or have received systemic treatment.
Cohort 2 of Phase II: Patients with histologically confirmed resectable stage II-III NSCLC (according to the eighth edition of AJCC staging) who have not received previous systemic treatment; among them, N2 is defined as single-station mediastinal lymph node non-bulky metastasis (lymph node short diameter <2 cm) confirmed by imaging and pathology, with expected complete resection.
2. Previous tumor tissue or pleural effusion or blood sample confirmed positive for EGFR mutation.
3. Measurable lesions at baseline according to RECIST 1.1 criteria.

Key exclusion criteria (14 listed)

1. Participated in other therapeutic clinical trials within 28 days prior to the first dose。
2. Patients underwent major organ surgery within 4 weeks prior to the first dose.or is expected to undergo major surgery during the study.
3. Have received lung field or whole-brain radiotherapy within 28 days before the first study drug administration, or has received palliative local radiotherapy within 14 days before the first dose。
4. Patients received antitumour traditional Chinese medicine within 1 weeks prior to the first dose，and received local anti-tumor drug therapy (such as thoracic or abdominal perfusion, etc.) within 14 days or within 5 half-lives (whichever is shorter)。
5. Patients with malignancies other than tumors treated in this study (except: malignancies that are cured and have not recurred within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type).

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
PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based ChemotherapyFor non-squamous NSCLC patients：Pemetrexed (500 mg/m2) plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily。 For squamous NSCLC subjects: Docetaxel（75 mg/m² ）or paclitaxel（175 mg/mg） plus carboplatin (AUC5) or cisplatin（75 mg/m²）on Day 1 of 21day cycles (every 3 weeks) , followed by PLB1004 80mg/160mg/240mg oral once daily.	Drug	phase Ib Dose Escalation
PLB1004 80mg/160mg/240mg oral once daily Combined with Platinum-Based ChemotherapyMultiple doses of PLB1004 for oral administration. Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks).	Drug	phase Ib Dose Expansion
RP2D of PLB1004 oral once daily Combined with Platinum-Based ChemotherapyRP2D of PLB1004 as determined during Phase Ib . Platinum-based chemotherapy is combined and administered on Day 1 of 21days（every 3 weeks）.	Drug	phase II Cohort1
RP2D of PLB1004 oral once daily Combined with Platinum-Based ChemotherapyRP2D of PLB1004 as determined during Phase Ib，patients will undergo surgical treatment after 3 cycles of combination therapy with platinum-based chemotherapy. Post-surgery, they will receive an additional cycle of platinum-based chemotherapy followed by 13 cycles of maintenance therapy with PLB1004.	Drug	phase II Cohort2

Primary outcome

Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability])
Time frame: 12 months
To evaluate the tolerability and safety of PLB1004 combined with platinum-based doublet chemotherapy in patients with epidermal growth factor receptor (EGFR) mutation positive NSCLC
Phase Ib： Incidence of dose-limiting toxicities (DLT) as defined in the protocol
Time frame: 12 months
To determine the maximum tolerated dose (MTD) and/or dose-limiting toxicities (DLT) of combination therapy of PLB1004 combined with platinum-based doublet chemotherapy in patients with EGFR mutation positive NSCLC
Phase Ib： Recommended Phase II Dose (RP2D)
Time frame: 12 months
To determine the recommended phase II dose (RP2D) of PLB1004 in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation positive NSCLC
Phase Ib： Overall Response Rate (ORR）
Time frame: 24 months
ORR is defined as the proportion of subjects with confirmed best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1
Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D in subjects with EGFR mutation positive locally advanced or metastatic NSCLC
Time frame: 36 months
Objective response rate (ORR) as evaluated by the investigator according to RECIST v1.1
Phase II： To evaluate the efficacy of PLB1004 in combination with platinum-based doublet chemotherapy at the RP2D RP2D in newly diagnosed resectable stage II-III NSCLC subjects with EGFR mutation positive
Time frame: 12 months
Major pathological response (MPR) evaluated by the blinded independent pathology review committee (BIPR)

13 secondary outcomes

Cmax
Time frame: 12 months
DOR
Time frame: 36 months
PFS
Time frame: 36 months
Tmax
Time frame: 12 months
(AUC0-t）
Time frame: 12 months
T 1/2
Time frame: 12 months
CL/F
Time frame: 12 months
Vz/F
Time frame: 12 months
DCR
Time frame: 36 months
OS
Time frame: 36 months
EFS
Time frame: 36 months
pCR
Time frame: 36 months
DFS
Time frame: 36 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 28 Oct 2026.
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.

Shun Lu M.D, Ph.D. contact

86-21-22200000

shunlu@sjtu.edu.cn

Shun Lu M.D, Ph.D. principal investigator

Shanghai Chest Hospital

Deng Hou Master study director

Avistone Pharmaceutical（Ningbo）Co., LTD.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 Shun Lu M.D, Ph.D. (86-21-22200000, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib： Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]) (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07063329.

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 28 Oct 2026.