Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
NCT ID: NCT04930432
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
400 participants
INTERVENTIONAL
2021-09-24
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1: dose escalation and dose expansion
Participants will receive intravenous infusion of MCLA-129 every two weeks (Q2W) or every weeks (QW) at different dose in each dose level.
MCLA-129
MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.
Part 2: cohort expansion
Participants will receive intravenous infusion of MCLA-129 every two weeks (Q2W) at the recommended Phase II dose (RP2D) in each cohort.
MCLA-129
MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.
Interventions
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MCLA-129
MCLA-129 will be administered by intravenous infusion on the 28-day treatment cycle.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
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.
* 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
* 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 cancer: patients with colorectal cancer 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 \[JNJ-61186372\], EMB-01 or GB263T 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, or concomitantly with symptomatic brain metastases, or new therapy naive brain metastases. For cohorts E and F: 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 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.
18 Years
ALL
No
Sponsors
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Betta Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jie Wang, PhD
Role: STUDY_CHAIR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Locations
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Affiliated Hospital of Hebei University
Baoding, , China
Beijing Cancer Hospital
Beijing, , China
Beijing Friendship Hospital, Capital Medical University
Beijing, , China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , China
Peking University International Hospital
Beijing, , China
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, , China
Ji Lin Cancer Hospital
Changchun, , China
Hunan Cancer Hospital
Changsha, , China
Hunan Cancer Hospital
Changsha, , China
The Second Xiangya Hospital of Central South University
Changsha, , China
Sichuan Cancer Hospital
Chengdu, , China
West China Hospital, Sichuan University
Chengdu, , China
Chifeng Municipal Hospital
Chifeng, , China
Army Medical Center of PLA
Chongqing, , China
Chongqing University Cancer Hospital
Chongqing, , China
China-Japan Union Hospitai Of Jilin University
Ch’ang-ch’un, , China
The First Affiliated Hospital of Dalian Medical University
Dalian, , China
Fujian Cancer Hospital
Fuzhou, , China
Fuzhou Pulmonary Hospital of Fujian
Fuzhou, , China
The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Fuzhou, , China
First Affiliated Hospital Of Gannan Medical University
Ganzhou, , China
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, , China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, , China
The Frist Affiliated Hospital of Guangzhou Medical College
Guangzhou, , China
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, , China
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Hanzhong Central Hospital
Hanzhong, , China
Cancer Hospital affiliated to Harbin Medical University
Ha’erbin, , China
Harbin Medical University cancer hospital
Ha’erbin, , China
The Second Hospital of Anhui Medical University
Hefei, , China
Inner Mongolia People's Hospital
Hohhot, , China
Jiangxi cancer hospital
Jiangxi, , China
The First Hospital of Jilin University
Jilin, , China
Shandong Cancer Hospital & institute
Jinan, , China
Yunnan Cancer Hospital
Kunming, , China
The First Hospital of Lanzhou University
Lanzhou, , China
General Hospital of Eastern Theater Command
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Nantong Tumor Hospital
Nantong, , China
Qingdao Central Hospital
Qingdao, , China
The Affiliated Hospital of Qingdao University
Qingdao, , China
First Hospital of Qinhuangdao
Qinhuangdao, , China
ShangHai Chest Hospital
Shanghai, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
Liaoning Cancer Hospital & Institute
Shenyang, , China
The First Hospital of China Medical University
Shenyang, , China
Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital
Shenzhen, , China
Shenzhen People's Hospital
Shenzhen, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Shanxi Provincial Cancer Hospital
Taiyuan, , China
Taizhou Hospital of Zhejiang Province
Taizhou, , China
General Hospital of Tianjin Medical University
Tianjin, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, , China
Tonghua Central Hospital
Tonghua, , China
Weifang People's Hospital
Weifang, , China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, , China
Hubei Cancer Hospital
Wuhan, , China
Renmin Hospital of Wuhan University/Hubei General Hospital
Wuhan, , China
Union Hospital, Tongji Medical College Huazhong University of Science and Technolog
Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, , China
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Wuhu, , China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, , China
The First Affiliated Hospital Of Xiamen University
Xiamen, , China
Xuzhou Central Hospital
Xuzhou, , China
Yantai Yuhuangding Hospital
Yantai, , China
The No. 2 People's Hospital of Yibin Sichuan
Yibin, , China
Hospital of Ningxia Medical University
Yinchuan, , China
He Nan Cancer Hospital
Zhengzhou, , China
Henan Provincial People's Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Henan Provincial People's Hospital
Zhenzhou, , China
Countries
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Central Contacts
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Other Identifiers
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BTP-21711
Identifier Type: -
Identifier Source: org_study_id