Non-Small Cell Lung CancerPhase 2NCT06885840

Study of MCLA-129 in the Treatment of Advanced Non-small Cell Lung Cancer with AGA and MET Amplification.

A Phase 2 study testing MCLA-129 in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 20 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a multi-center, open-label, phase II clinical study of MCLA-129 as monotherapy in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification to evaluate the efficacy, safety, pharmacokinetic characteristics of MCLA-129. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Small Cell Lung Cancer
What is being tested?: MCLA-129
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 20 sitesChina
Study dates: 31 Mar 2025to Sep 2028
Phase: Phase 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

Subjects are ≥ 18 years of age, regardless of gender.
Subjects must have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.
Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts:
Cohort 1 and Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which includes 1) first-generation or second-generation EGFR-TKIs, with T790M mutation requiring third-generation EGFR-TKIs and platinum-based chemotherapy; or 2) first-generation or second-generation EGFR-TKIs, with T790M mutation negative or unknown status.
Subjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs.
Subjects in Cohort 2: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

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Cohort 3 and Cohort 4: Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy.
Subjects in Cohort 3: Patients with MET amplification after failure of treatment with the corresponding driver gene inhibitors.
Subjects in Cohort 4: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.
Subjects must have measurable lesions that meet the definition of RECIST v1.1. Selected target lesions must meet one of the following two criteria: 1) no prior local therapy or radiation or 2) subsequent progression occurs within the prior local therapy area as determined by RECIST v1.1..
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Expected survival ≥3 months.
Have certain functions of organ systems (no blood transfusion or use of blood component or G-CSF support within 14 days before testing), defined as follows:
Absolute neutrophil count (ANC) ≥1.5×10^9 /L.
Platelet count (PLT）≥75×10^9 /L.
Hemoglobin (HGB) ≥100 g/L.
Serum albumin ≥ 30 g/L.
Total bilirubin ≤1.5 times the upper limit of normal (ULN).
Alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤3×ULN.
Creatinine ≤1.5×ULN. If creatinine is >1.5×ULN, creatinine clearance ≥50 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine creatinine clearance ≥50 mL/min is measured, the patients can still be enrolled.
Willing and able to follow the trial and follow-up procedures.
Able to understand the nature of the trial and voluntarily sign the written informed consent form.

Who cannot join

Have received an investigational product or antitumor drug treatment (including known anti-tumor traditional Chinese medicine treatment) within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer) (for a drug with a long half-life, it is required that the interval from the last dose to be at most 4 weeks; for chemotherapy with delayed toxicity, such as nitrosourea or mitomycin C, it shall be 6 weeks before [the treatment]).
Have undergone a major surgery and radiotherapy (local palliative radiotherapy is allowed 2 weeks or more prior to the first dose) within 4 weeks prior to the first dose of MCLA-129.
Have previously received systemic anti-tumor therapy beyond the fourth line (excluding maintenance therapy).
Prior use of EGFR/c-Met bispecific antibody or ADC drugs (Amivantamab [JNJ-61186372], EMB-01, GB263T, PM1080/HS-20117, TAVO412, YH013/DM005, AZD9592, or SHR-9839).
Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolved to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.
Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolved to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.

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Have had other malignancies within the past 3 years, except for cancers that have been totally cured or locally cured, such as basal or squamous cell carcinoma of the skin, cervical cancer in situ, or breast cancer in situ.
Patients with primary malignant tumor of central nervous system, or metastases to meninges, or concomitantly with symptomatic brain metastases, or new therapy naive brain metastases.
Note: Patients with brain metastases who have received treatment for brain metastases (including systemic and local therapies against brain metastases) with no obvious symptoms and stable condition, and do not require drug therapy such as steroids and/or dehydration to reduce intracranial pressure within 2 weeks before enrollment and have no risk of brain bleeding can be enrolled.
With clinically significant cardiovascular and cerebrovascular diseases.
Arterial thromboembolism, deep vein thrombosis or lung embolism diagnosed within 3 month before first administration of the investigational drug. Non-obstructive catheter related clot and other clinically irrelevant thrombosis are not included in the exclusion criteria. Patients with a history of related thrombosis diagnosed 3 months ago must be clinically stable for at least 4 weeks before initial administration.
With any of the following medical history within 6 months before first administration of the investigational drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary or peripheral artery bypass, or any acute coronary syndrome.
With abnormal ECG corrected QT interval (QTcF) at rest in the screening period. Remeasurement is made twice at intervals of more than 5 minutes. For average QTcF of 3 ECG inspections: male: ≥ 450 msec, and female: ≥ 470 msec. With clinically significant abnormal heart rate, conduction, and ECG form at rest, e.g. complete left bundle branch block, third-degree conduction block, second-degree conduction block, and PR interval > 250 msec, double law, triple law, preexcitation syndrome, etc.
Poorly controlled hypertension in the investigator's opinion (systolic blood pressure > 180 mmHg, or diastolic blood pressure > 100 mmHg).
New York Heart Association Grade III-IV congestive heart failure, or hospitalization due to congestive heart failure within 6 months before first administration of the investigational drug.
Pericarditis/clinically significant pericardial effusion.
Cardiomyopathy.
Other clinically significant cardiovascular disorders as believed by investigators.
Active hepatitis B (positive hepatitis B surface antigen (HBsAg) and serum HBV DNA ≥ 2,000 IU/mL [equivalent to 104 copies/mL]), positive hepatitis C virus antibody, HIV antibody and treponema pallidum antibody.
Subjects with a history of interstitial lung disease or current clinical evidence of interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonitis.
Presence of a serious disease or medical condition currently, including but not limited to uncontrolled active infection, uncontrolled pleural or peritoneal effusion, and clinically significant pulmonary, metabolic or psychiatric diseases.
Females of childbearing potential, pregnant or breastfeeding women with a positive serum pregnancy test 7 days before the start of treatment, and male and female subjects who are unwilling to use effective contraceptive measures or plan to have a child throughout the treatment period and within 3 months after the end of treatment.
Patients with known allergic reactions and hypersensitivity reactions, or be allergic to MCLA-129 or any of its excipients.
Patients with poor compliance, inability or unwillingness to follow the study and/or follow-up procedure listed in the protocol, or patients who are not suitable to participate in this trial, as determined by the investigator.

Trial locations and contacts

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

Wanlin Chen, Master contact

18258270120

wanlin.chen@bettapharma.com

City, postcode or hospital

20 sites in 1 country

China20 sites

Hebei University Affiliated Hospital
Baoding, Hebei
Beijing Chest Hospital
Beijing
Jilin Cancer Hospital
Changchun, Jilin
The First Hospital of Jilin University
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
Dongguan People's Hospital
Dongguan, Guangdong
Foshan First People's Hospital
Foshan, Guangdong
Guangdong General Hospital
Guangzhou, Guangdong
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Harbin Medical University Affiliated Cancer Hospital
Harbin, Heilongjiang
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Shandong Cancer Hospital
Jinan, Shandong
The First Hospital of Lanzhou University
Lanzhou, Gansu
Nantong Cancer Hospital
Nantong, Jiangsu
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Henan Cancer Hospital
Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multi-cohort, Open-label Phase II Study to Evaluate the Efficacy and Safety of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Gene Alterations and MET Amplification.

Read the detailed description

This is a multi-center, open-label, monotherapy, multi-cohort phase II study of MCLA-129 in patients with advanced non-small cell lung cancer (NSCLC) with actionable gene alterations and MET amplification, designed to evaluate the efficacy, safety, and PK profiles of MCLA-129 in the target population.

Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts:

Cohort 1 and Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which includes 1) first-generation or second-generation EGFR-TKIs, with T790M mutation requiring third-generation EGFR-TKIs and platinum-based chemotherapy; or 2) first-generation or second-generation EGFR-TKIs, with T790M mutation negative or unknown status.

Subjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs.

Subjects in Cohort 2: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

Cohort 3 and Cohort 4: Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy.

Subjects in Cohort 3: Patients with MET amplification, after failure of treatment with the corresponding driver gene inhibitors.

Subjects in Cohort 4 should also meet: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

Conditions: Non-Small Cell Lung Cancer
Being tested: MCLA-129
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.

MCLA-129Drug
MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.

Study groups in NCT06885840
Study group	Role	What they receive
Cohort 1	Experimental	Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment and with MET amplification after failure of treatment with EGFR-TKIs. Receives: Drug: MCLA-129
Cohort 2	Experimental	Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment and with disease progression or intolerance after MET inhibitors and who have benefited from such treatment. Receives: Drug: MCLA-129
Cohort 3	Experimental	Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy also with MET amplification after failure of treatment with the corresponding driver gene inhibitors. Receives: Drug: MCLA-129
Cohort 4	Experimental	Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors, platinum-based chemotherapy and with disease progression or intolerance after MET inhibitors and who have benefited from such treatment. Receives: Drug: MCLA-129

What is being measured

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

Overall Response Rate (ORR)
To evaluate the efficacy of MCLA-129 at RP2D in patients with advanced NSCLC and other solid tumors in each cohort in Part 2 in terms of overall response rate (ORR)
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years

Secondary outcomes (9)

Clinical benefit rate (CBR)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of clinical benefit rate (CBR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Disease Control Rate (DCR)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of disease control rate (DCR)
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Progression-Free Survival (PFS)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of progression-free survival (PFS).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Duration of Response (DOR)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of duration of response (DOR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Time to response (TTR)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of time to response (TTR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Overall Survival (OS)
To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of overall survival (OS).
Measured: From date of first treatment every 6 weeks until death or withdrawal, whichever came first, approximately 2 years.
Treatment-Emergent Adverse Event (TEAE)
To evaluate the safety of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of treatment-emergent adverse event (TEAE).
Measured: Until 30 days after the last dosing
Area under the concentration versus time curve [AUC0-∞]
To evaluate the population PK profile of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of area under the concentration versus time curve [AUC0-∞].
Measured: : Until 30 days after the last dosing.
Anti-Drug Antibody (ADA)
To assess the Incidence of anti-drug antibodies in serum blood against MCLA-129 following administration of MCLA-129.
Measured: Until 30 days after the last dosing.

Timeline

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

31 Mar 2025Sep 2028

First posted20 Mar 2025
Study start31 Mar 2025 (estimated)
Primary completionApr 2028 (estimated)
Study completionSep 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
More trials run by Betta Pharmaceuticals 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 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06885840
Sponsor's protocol ID: BTP-21723
Status last verified: Mar 2025
First submitted: 14 Mar 2025
Last updated: 20 Mar 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 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-cohort, Open-label Phase II Study to Evaluate the Efficacy and Safety of the Anti-EGFR/c-Met Bispecific Antibody MCLA-129 in Patients with Advanced Non-Small Cell Lung Cancer with Actionable Gene Alterations and MET Amplification.
ClinicalTrials.gov ID: NCT06885840
Acronym / sponsor ID: BTP-21723
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
Study start: 31 Mar 2025 (estimated)
Primary completion: Apr 2028 (estimated)
Study completion: Sep 2028 (estimated)
First posted: 20 Mar 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

Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts:

Subjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs.

Subjects in Cohort 2: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

Subjects in Cohort 3: Patients with MET amplification, after failure of treatment with the corresponding driver gene inhibitors.

Subjects in Cohort 4 should also meet: Patients who experienced disease progression or intolerance after MET inhibitors and benefited from such treatment.

Study design

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

Arm	Type	Receives
Cohort 1	Experimental	Drug: MCLA-129Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment and with MET amplification after failure of treatment with EGFR-TKIs.
Cohort 2	Experimental	Drug: MCLA-129Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment and with disease progression or intolerance after MET inhibitors and who have benefited from such treatment.
Cohort 3	Experimental	Drug: MCLA-129Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors and platinum-based chemotherapy also with MET amplification after failure of treatment with the corresponding driver gene inhibitors.
Cohort 4	Experimental	Drug: MCLA-129Patients with advanced NSCLC with previously detected actionable gene alterations who had progressed after treatment with corresponding inhibitors, platinum-based chemotherapy and with disease progression or intolerance after MET inhibitors and who have benefited from such treatment.

Who may qualify

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

Key inclusion criteria (22 listed)

Subjects are ≥ 18 years of age, regardless of gender.
Subjects must have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.
Subjects who must experience disease progression or intolerance after standard treatment eligible through screening will be divided into the following 4 cohorts:
Cohort 1 and Cohort 2: Patients with advanced NSCLC with previously detected EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation) who have progressed after prior standard treatment which includes 1) first-generation or second-generation EGFR-TKIs, with T790M mutation requiring third-generation EGFR-TKIs and platinum-based chemotherapy; or 2) first-generation or second-generation EGFR-TKIs, with T790M mutation negative or unknown status.
Subjects in Cohort 1: Patients with MET amplification after failure of treatment with EGFR-TKIs.

Key exclusion criteria (24 listed)

Have received an investigational product or antitumor drug treatment (including known anti-tumor traditional Chinese medicine treatment) within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer) (for a drug with a long half-life, it is required that the interval from the last dose to be at most 4 weeks; for chemotherapy with delayed toxicity, such as nitrosourea or mitomycin C, it shall be 6 weeks before [the treatment]).
Have undergone a major surgery and radiotherapy (local palliative radiotherapy is allowed 2 weeks or more prior to the first dose) within 4 weeks prior to the first dose of MCLA-129.
Have previously received systemic anti-tumor therapy beyond the fourth line (excluding maintenance therapy).
Prior use of EGFR/c-Met bispecific antibody or ADC drugs (Amivantamab [JNJ-61186372], EMB-01, GB263T, PM1080/HS-20117, TAVO412, YH013/DM005, AZD9592, or SHR-9839).
Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolved to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.

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
MCLA-129MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.	Drug	Cohort 1, Cohort 2, Cohort 3, Cohort 4

Primary outcome

Overall Response Rate (ORR)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
To evaluate the efficacy of MCLA-129 at RP2D in patients with advanced NSCLC and other solid tumors in each cohort in Part 2 in terms of overall response rate (ORR)

9 secondary outcomes

Clinical benefit rate (CBR)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Disease Control Rate (DCR)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Progression-Free Survival (PFS)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Duration of Response (DOR)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Time to response (TTR)
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years.
Overall Survival (OS)
Time frame: From date of first treatment every 6 weeks until death or withdrawal, whichever came first, approximately 2 years.
Treatment-Emergent Adverse Event (TEAE)
Time frame: Until 30 days after the last dosing
Area under the concentration versus time curve [AUC0-∞]
Time frame: : Until 30 days after the last dosing.
Anti-Drug Antibody (ADA)
Time frame: Until 30 days after the last dosing.

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 20 Mar 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.

Wanlin Chen, Master contact

18258270120

wanlin.chen@bettapharma.com

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MCLA-129 in people with Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 20 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 22 inclusion and 24 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: opening soon, as of the sponsor's last update on 20 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 20 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 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 Wanlin Chen, Master (18258270120, wanlin.chen@bettapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years). 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 NCT06885840.

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 20 Mar 2025.