Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Dual-Targeting antibody enters human trials for Hard-to-Treat cancers

NCT ID NCT04930432

Disease control Sponsor: Betta Pharmaceuticals Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing an experimental drug called MCLA-129 in people with advanced solid tumors, including non-small cell lung cancer, head and neck cancer, and colorectal cancer. The drug is a bispecific antibody designed to attach to two cancer-related proteins (EGFR and c-Met) to block tumor growth. The trial aims to find the safest dose and see if the drug can shrink tumors. About 400 participants will be enrolled across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MCLA-129 (a bispecific antibody that targets two cancer-related proteins, EGFR and c-Met)
What this could lead to
If successful, this could provide a new treatment option for people with advanced solid tumors who have run out of standard therapies.
What could go wrong
This is an early-phase trial (Phase I/II) with a small number of participants, so the drug may not prove effective or may cause significant side effects. It is not yet known if it will work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2021

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. 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. Exclusion Criteria: * 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. * 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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal cancer colorectal neoplasm gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck cancer Head and Neck Neoplasms head and neck squamous cell carcinoma neoplasm non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Head and neck cancer Non-small cell lung cancer Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    87 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Hebei University

    RECRUITING

    Baoding, China

  • Army Medical Center of PLA

    RECRUITING

    Chongqing, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Beijing Friendship Hospital, Capital Medical University

    RECRUITING

    Beijing, China

  • Beijing Tongren Hospital

    RECRUITING

    Beijing, China

  • Cancer Hospital affiliated to Harbin Medical University

    RECRUITING

    Ha’erbin, China

  • Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital

    RECRUITING

    Shenzhen, China

  • Cancer Hospital of Shantou University Medical College

    RECRUITING

    Shantou, China

  • Cancer Hospital of The University of Chinese Academy of Sciences

    RECRUITING

    Hangzhou, China

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Beijing, China

  • Cangzhou Hospital of Integrated TCM-WM·Hebei

    RECRUITING

    Cangzhou, China

  • Chifeng Municipal Hospital

    RECRUITING

    Chifeng, China

  • China-Japan Union Hospitai Of Jilin University

    RECRUITING

    Ch’ang-ch’un, China

  • Chongqing University Cancer Hospital

    RECRUITING

    Chongqing, China

  • First Affiliated Hospital Of Gannan Medical University

    RECRUITING

    Ganzhou, China

  • First Hospital of Qinhuangdao

    RECRUITING

    Qinhuangdao, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Fuzhou Pulmonary Hospital of Fujian

    RECRUITING

    Fuzhou, China

  • General Hospital of Eastern Theater Command

    RECRUITING

    Nanjing, China

  • General Hospital of Tianjin Medical University

    RECRUITING

    Tianjin, China

  • Guangdong Province Traditional Chinese Medical Hospital

    RECRUITING

    Guangzhou, China

  • Guangxi Medical University Cancer Center

    RECRUITING

    Nanning, China

  • Hanzhong Central Hospital

    RECRUITING

    Hanzhong, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, China

  • Harbin Medical University cancer hospital

    RECRUITING

    Ha’erbin, China

  • He Nan Cancer Hospital

    RECRUITING

    Zhengzhou, China

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

    RECRUITING

    Henan, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhenzhou, China

  • Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, China

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Inner Mongolia People's Hospital

    RECRUITING

    Hohhot, China

  • Ji Lin Cancer Hospital

    RECRUITING

    Changchun, China

  • Jiangsu Cancer Hospital

    RECRUITING

    Nanjing, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, China

  • Jiangxi cancer hospital

    RECRUITING

    Jiangxi, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, China

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, China

  • Nantong Tumor Hospital

    RECRUITING

    Nantong, China

  • Peking University International Hospital

    RECRUITING

    Beijing, China

  • Qingdao Central Hospital

    RECRUITING

    Qingdao, China

  • Renmin Hospital of Wuhan University/Hubei General Hospital

    RECRUITING

    Wuhan, China

  • Shandong Cancer Hospital & institute

    RECRUITING

    Jinan, China

  • ShangHai Chest Hospital

    RECRUITING

    Shanghai, China

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

    RECRUITING

    Shanghai, China

  • Shanxi Provincial Cancer Hospital

    RECRUITING

    Taiyuan, China

  • Shenzhen People's Hospital

    RECRUITING

    Shenzhen, China

  • Sichuan Cancer Hospital

    RECRUITING

    Chengdu, China

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

    RECRUITING

    Guangzhou, China

  • Taizhou Hospital of Zhejiang Province

    RECRUITING

    Taizhou, China

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

    RECRUITING

    Fuzhou, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, China

  • The Fifth Medical Center of PLA Ceneral Hospital

    RECRUITING

    Beijing, China

  • The First Affiliated Hospital Of Xiamen University

    RECRUITING

    Xiamen, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, China

  • The First Affiliated Hospital of Bengbu Medical University

    RECRUITING

    Bengbu, China

  • The First Affiliated Hospital of Dalian Medical University

    RECRUITING

    Dalian, China

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, China

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

    RECRUITING

    Wuhu, China

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi'an, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, China

  • The First Hospital of Jilin University

    RECRUITING

    Jilin City, China

  • The First Hospital of Lanzhou University

    RECRUITING

    Lanzhou, China

  • The Frist Affiliated Hospital of Guangzhou Medical College

    RECRUITING

    Guangzhou, China

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

    RECRUITING

    Yibin, China

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • The Second Hospital of Anhui Medical University

    RECRUITING

    Hefei, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • Tonghua Central Hospital

    RECRUITING

    Tonghua, China

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

    RECRUITING

    Wuhan, China

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

    RECRUITING

    Wuhan, China

  • Weifang People's Hospital

    RECRUITING

    Weifang, China

  • West China Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Xiangya Hospital of Central South University

    RECRUITING

    Changsha, China

  • Xuzhou Central Hospital

    RECRUITING

    Xuzhou, China

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, China

  • Yunnan Cancer Hospital

    RECRUITING

    Kunming, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

  • Zhongnan Hospital Affiliated to Wuhan University

    RECRUITING

    Wuhan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.