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Solid TumorPhase 1/2NCT04930432

Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

A Phase 1/2 study testing MCLA-129 in people with Solid Tumor and Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 87 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
Search all trials

Trial summary

This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129. Read more about this study

Who is it for?
Ages 18 years and older
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
400 participants
Where
87 sitesChina
Study dates
24 Sep 2021to 30 Dec 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

  • Subjects are ≥ 18 years of age, regardless of gender.
  • Subjects must have histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors (including but not limited to head and neck cancer, colorectal cancer, etc.), have disease progression after standard treatment, or are intolerant to standard treatment, or refuse standard treatment (Refusal of standard treatment does not apply to Part 2).
  • For Part 1, subjects must be diagnosed with EGFR positive and/or MET positive by testing.
  • For patients with advanced NSCLC, EGFR positive is defined as: EGFR mutation or EGFR amplification. MET positive is defined as: MET amplification or MET exon 14 skipping mutation.
  • For patients with other advanced solid tumors other than NSCLC, EGFR positive is defined as: High EGFR expression or EGFR amplification. MET positive is defined as: c-Met high expression or MET amplification.
  • For Part 2, patients shall meet the inclusion criteria for each cohort by biomarker testing.
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  • Cohort A: Patients with advanced NSCLC who are previously diagnosed with EGFR mutations and treated with third-generation EGFR-TKIs for drug resistance.
  • Cohort B: Advanced NSCLC patients diagnosed with EGFR exon 20 insertion mutation (Exon20ins).
  • Cohort C: Advanced NSCLC patients with MET amplification. Cohort D: Advanced NSCLC patients with MET exon 14 skipping mutation (Exon14 skipping).
  • Cohort E: Patients with locally advanced or recurrent metastatic colorectal cancer (CRC) could not undergo curative treatment.
  • Cohort F: Other advanced solid tumors that have failed or are intolerant to standard therapy.
  • Cohort G: Patients with locally advanced or metastatic MET-amplified or MET-overexpressing other driver gene-negative non-small cell lung cancer, gastric/gastroesophageal junction adenocarcinoma [including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma], or recurrent/metastatic [R/M] head and neck squamous cell carcinoma [primary sites: oral cavity, oropharynx, hypopharynx, or larynx], who are not candidates for curative treatment.
  • For subjects in the dose escalation phase of Part 1, evaluable lesions must be present; other subjects must have measurable lesions that meet the definition of RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Expected survival ≥3 months.
  • Have adequate organ function (no blood transfusion or use of blood component or G-CSF support within 14 days before testing).
  • 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

  • For colorectal cancer subjects, HER-2 positivity (IHC 2+/3+ or FISH/NGS+) confirmed by local or central laboratory genetic testing.
  • Have received an investigational product or anti-tumor drug treatment within 14 days before the first dose of MCLA-129 or within 5 half-lives of the drug (whichever is longer). For cohort E1, the interval between the last dose of EGFR monoclonal antibody and the first dose of MCLA-129 was less than 6 months.
  • 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.
  • For patients with colorectal cancerr, head and neck squamous cell carcinoma, or gastric/gastroesophageal junction adenocarcinoma: patients who have previously received systemic anti-tumor therapy beyond the third line (excluding maintenance therapy).
  • For subjects with non-small cell lung cancer only: have received more than 2 prior lines of cytotoxic chemotherapy for locally advanced or metastatic diseases (excluding maintenance therapy).
  • For advanced NSCLC patients with EGFR Exon20ins mutation: have received prior EGFR-TKI therapy (e.g., poziotinib, TAK-788, DZD9008, CLN-081, or furmonertinib, etc.) that is known to be effective against Exon20ins.
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  • Prior use of EGFR/c-Met bispecific antibody or ADC drugs (such as Amivantamab, EMB-01, GB263T, PM1080/HS-20117, TAVO412, YH013/ DM005, SHR-9839 or AZD9592 etc.).
  • Prior to the first dose of MCLA-129, previous treatment-related toxicities have not resolve to Grade 1 or below (CTCAE 5.0 criteria), except for alopecia.
  • 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, spinal cord compression, or at risk of cerebral hemorrhage, or concomitantly with symptomatic brain metastases, or new therapy naive brain metastases. For cohorts E, F and G (excluding NSCLC patients): Patients with known brain metastases and/or meningeal metastases, or primary malignant tumor of central nervous system. Subjects with neurological symptoms shall have a brain CT/MRI scan to exclude brain metastases.
  • With clinically significant cardiovascular and cerebrovascular diseases.
  • Active hepatitis B (positive hepatitis B surface antigen (HBsAg) or core antibody (HBcAb) 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, radiation pneumonitis or pulmonary fibrosis. Subjects who could not be ruled out for suspected interstitial lung disease/pulmonary fibrosis through imaging examinations during screening, or those with uncontrolled/unstable non-infectious pneumonitis/pulmonary inflammation are excluded.
  • Presence of a serious disease or medical condition currently, including but not limited to uncontrolled active infection, uncontrolled pleural or peritoneal effusion, unstable/uncontrolled tuberculosis, active gastrointestinal diseases, gastrointestinal obstruction or perforation risks, 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

87 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

87 sites in 1 country

China87 sites, 87 recruiting

  • Affiliated Hospital of Hebei University

    Baoding

    Recruiting

  • Beijing Cancer Hospital

    Beijing

    Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing

    Recruiting

  • Beijing Tongren Hospital

    Beijing

    Recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

    Recruiting

  • Peking University International Hospital

    Beijing

    Recruiting

  • The Fifth Medical Center of PLA Ceneral Hospital

    Beijing

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu

    Recruiting

  • Cangzhou Hospital of Integrated TCM-WM·Hebei

    Cangzhou

    Recruiting

  • China-Japan Union Hospitai Of Jilin University

    Ch’ang-ch’un

    Recruiting

  • Ji Lin Cancer Hospital

    Changchun

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha

    Recruiting

  • Xiangya Hospital of Central South University

    Changsha

    Recruiting

  • Sichuan Cancer Hospital

    Chengdu

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu

    Recruiting

  • Chifeng Municipal Hospital

    Chifeng

    Recruiting

  • Army Medical Center of PLA

    Chongqing

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Recruiting

  • The First Affiliated Hospital of Dalian Medical University

    Dalian

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    Recruiting

  • Fuzhou Pulmonary Hospital of Fujian

    Fuzhou

    Recruiting

  • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China

    Fuzhou

    Recruiting

  • First Affiliated Hospital Of Gannan Medical University

    Ganzhou

    Recruiting

  • Guangdong Province Traditional Chinese Medical Hospital

    Guangzhou

    Recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou

    Recruiting

  • The Frist Affiliated Hospital of Guangzhou Medical College

    Guangzhou

    Recruiting

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou

    Recruiting

  • Cancer Hospital affiliated to Harbin Medical University

    Ha’erbin

    Recruiting

  • Harbin Medical University cancer hospital

    Ha’erbin

    Recruiting

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou

    Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    Recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Recruiting

  • Hanzhong Central Hospital

    Hanzhong

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin

    Recruiting

  • The Second Hospital of Anhui Medical University

    Hefei

    Recruiting

  • Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)

    Henan

    Recruiting

  • Inner Mongolia People's Hospital

    Hohhot

    Recruiting

  • Jiangxi cancer hospital

    Jiangxi

    Recruiting

  • The First Hospital of Jilin University

    Jilin City

    Recruiting

  • Shandong Cancer Hospital & institute

    Jinan

    Recruiting

  • Yunnan Cancer Hospital

    Kunming

    Recruiting

  • The First Hospital of Lanzhou University

    Lanzhou

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Recruiting

  • General Hospital of Eastern Theater Command

    Nanjing

    Recruiting

  • Jiangsu Cancer Hospital

    Nanjing

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing

    Recruiting

  • Guangxi Medical University Cancer Center

    Nanning

    Recruiting

  • Nantong Tumor Hospital

    Nantong

    Recruiting

  • Qingdao Central Hospital

    Qingdao

    Recruiting

  • The Affiliated Hospital of Qingdao University

    Qingdao

    Recruiting

  • First Hospital of Qinhuangdao

    Qinhuangdao

    Recruiting

  • ShangHai Chest Hospital

    Shanghai

    Recruiting

  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

    Shanghai

    Recruiting

  • Cancer Hospital of Shantou University Medical College

    Shantou

    Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang

    Recruiting

  • The First Hospital of China Medical University

    Shenyang

    Recruiting

  • Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital

    Shenzhen

    Recruiting

  • Shenzhen People's Hospital

    Shenzhen

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    Recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan

    Recruiting

  • Taizhou Hospital of Zhejiang Province

    Taizhou

    Recruiting

  • General Hospital of Tianjin Medical University

    Tianjin

    Recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin

    Recruiting

  • Tonghua Central Hospital

    Tonghua

    Recruiting

  • Weifang People's Hospital

    Weifang

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Recruiting

  • Hubei Cancer Hospital

    Wuhan

    Recruiting

  • Renmin Hospital of Wuhan University/Hubei General Hospital

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College Huazhong University of Science and Technolog

    Wuhan

    Recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Recruiting

  • Zhongnan Hospital Affiliated to Wuhan University

    Wuhan

    Recruiting

  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)

    Wuhu

    Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

    Recruiting

  • The First Affiliated Hospital Of Xiamen University

    Xiamen

    Recruiting

  • Xuzhou Central Hospital

    Xuzhou

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai

    Recruiting

  • The No. 2 People's Hospital of Yibin Sichuan

    Yibin

    Recruiting

  • Hospital of Ningxia Medical University

    Yinchuan

    Recruiting

  • He Nan Cancer Hospital

    Zhengzhou

    Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Recruiting

  • Henan Provincial People's Hospital

    Zhenzhou

    Recruiting

Other trials in China

About this study

Official title: A Phase I/II Study of MCLA-129, a Human Anti-EGFR and Anti-c-Met Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors, Evaluating Safety, Pharmacokinetic Characteristics and Antitumor Activity

This is a multi-center, open-label, Phase I/II clinical study of MCLA-129 as monotherapy in patients with advanced solid tumors to evaluate the safety, pharmacokinetic characteristics and antitumor activity of MCLA-129.

Read the detailed description

This is a multicenter, open-label, single-agent phase I/II clinical study of MCLA-129 in patients with advanced solid tumors to evaluate the safety, pharmacokinetic profile, and antitumor activity of MCLA-129. The study consists of two parts: Part I is a phase I dose- finding study in patients with advanced solid tumors, including a dose escalation phase and a dose expansion phase; Part II is a phase II parallel cohort expansion study to further evaluate the efficacy, safety and PK profile of MCLA-129 in sub-cohorts of patients with advanced non-small cell lung cancer and other solid tumors.

Being tested
MCLA-129
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Head and Neck Neoplasms, Colorectal Neoplasms

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 NCT04930432
Study groupRoleWhat they receive
Part 1: dose escalation and dose expansionExperimentalParticipants will receive intravenous infusion of MCLA-129 every two weeks (Q2W) or every weeks (QW) at different dose in each dose level.
Receives: Drug: MCLA-129
Part 2: cohort expansionExperimentalParticipants will receive intravenous infusion of MCLA-129 every two weeks (Q2W) at the recommended Phase II dose (RP2D) in each cohort.
Receives: Drug: MCLA-129

What is being measured

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

  1. Dose-Limiting Toxicity (DLT) in Part 1

    To determine the dose-limiting toxicity (DLT) of single agent MCLA-129 in patients with advanced solid tumors in Part 1.

    Measured: First 28 days of treatment

  2. Maximum Tolerated Dose (MTD) in Part 1

    To determine the maximum tolerated dose (MTD) of single agent MCLA-129 in patients with advanced solid tumors in Part 1.

    Measured: First 28 days of treatment

  3. Overall Response Rate (ORR) in Part 2

    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

  4. Treatment-Emergent Adverse Event (TEAE) in Part 1 and 2

    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

Secondary outcomes (15)

  1. Half-life [t1/2] in Part 1 and 2

    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 half-life (t1/2)

    Measured: Until 30 days after the last dosing

  2. Apparent volume of distribution [VSS] in Part 1 and 2

    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 apparent volume of distribution [VSS]

    Measured: Until 30 days after the last dosing

  3. Maximum plasma concentration [Cmax] in Part 1 and 2

    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 maximum plasma concentration [Cmax]

    Measured: Until 30 days after the last dosing

  4. Time to reach maximum concentration [Tmax] in Part 1 and 2

    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 time to reach maximum concentration [Tmax]

    Measured: Until 30 days after the last dosing

  5. Area under the concentration versus time curve from time zero to time t [AUC0-t] in Part 1 and 2

    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 from time zero to time t [AUC0-t]

    Measured: Until 30 days after the last dosing

  6. Area under the concentration versus time curve [AUC0-∞] in Part 1 and 2

    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

  7. Overall Response Rate (ORR) in Part 1

    To evaluate the efficacy of MCLA-129 in patients with advanced NSCLC and other solid tumors in Part 1 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

  8. Disease Control Rate (DCR) in Part 1 and 2

    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

  9. Progression-Free Survival (PFS) in Part 1 and 2

    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

  10. Clinical benefit rate (CBR) in Part 1 and 2

    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

  11. Duration of Response (DOR) in Part 1 and 2

    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

  12. Time to response (TTR) in Part 1 and 2

    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

  13. Overall Survival (OS) in Part 1 and 2

    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

  14. Anti-Drug Antibody (ADA) in Part 1 and 2

    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

  15. Cytokines in Part 1

    To assess the changes in cytokine levels in serum blood following administration of MCLA-129

    Measured: Before and after each administration on day 1 and day 15

Timeline

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

  1. First posted18 Jun 2021
  2. Study start24 Sep 2021
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04930432
Sponsor's protocol ID
BTP-21711
Status last verified
Feb 2026
First submitted
31 May 2021
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MCLA-129 in people with Solid Tumor and Non-Small Cell Lung Cancer, run by Betta Pharmaceuticals Co., Ltd. at 87 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 18 inclusion and 17 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 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 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 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?

Dose-Limiting Toxicity (DLT) in Part 1 (time frame: First 28 days of treatment). 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?

On the ClinicalTrials.gov record for NCT04930432.

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 10 Feb 2026.

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