Actively Recruiting
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2026-02-10
400
Participants Needed
87
Research Sites
379 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are 18 years of age or older, any gender.
- Histologically or cytologically confirmed metastatic or unresectable advanced NSCLC or other solid tumors.
- Disease progression after standard treatment, intolerance to it, or refusal of standard treatment (refusal not allowed in Part 2).
- For Part 1, EGFR positive and/or MET positive status confirmed by testing.
- Meet specific biomarker criteria for each cohort in Part 2.
- Evaluable or measurable lesions according to RECIST v1.1.
- ECOG performance status of 0-1.
- Expected survival of at least 3 months.
- Adequate organ function without recent blood transfusion or growth factor support.
- Willingness and ability to follow study and follow-up procedures.
- Ability to understand and voluntarily sign informed consent.
You will not qualify if you...
- HER-2 positivity for colorectal cancer subjects.
- Recent investigational or anti-tumor drug treatment within 14 days or 5 half-lives before MCLA-129.
- Major surgery or radiotherapy within 4 weeks before first dose.
- More than third-line systemic therapy for colorectal, head and neck, or gastric cancers.
- More than two prior lines of chemotherapy for advanced NSCLC.
- Prior EGFR-TKI therapy effective against EGFR Exon20ins mutation in relevant patients.
- Prior use of EGFR/c-Met bispecific antibodies or ADC drugs.
- Unresolved treatment-related toxicities above Grade 1 (except alopecia).
- Other malignancies within past 3 years except certain cured cancers.
- Primary CNS malignancy, symptomatic brain metastases, or related neurological conditions.
- Clinically significant cardiovascular or cerebrovascular diseases.
- Active hepatitis B or C, HIV, or syphilis infections.
- History or evidence of interstitial lung disease or uncontrolled pulmonary inflammation.
- Serious uncontrolled medical conditions including infections, effusions, GI obstruction, or psychiatric diseases.
- Females of childbearing potential, pregnant or breastfeeding women not using effective contraception.
- Known allergies to MCLA-129 or its components.
- Poor compliance or inability to follow study procedures as judged by investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 87 locations
1
Affiliated Hospital of Hebei University
Baoding, China
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, China
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3
Beijing Friendship Hospital, Capital Medical University
Beijing, China
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4
Beijing Tongren Hospital
Beijing, China
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5
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
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6
Peking University International Hospital
Beijing, China
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7
The Fifth Medical Center of PLA Ceneral Hospital
Beijing, China
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8
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
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9
The First Affiliated Hospital of Bengbu Medical University
Bengbu, China
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10
Cangzhou Hospital of Integrated TCM-WM·Hebei
Cangzhou, China
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11
Ji Lin Cancer Hospital
Changchun, China
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12
Hunan Cancer Hospital
Changsha, China
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13
The Second Xiangya Hospital of Central South University
Changsha, China
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14
Xiangya Hospital of Central South University
Changsha, China
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15
Sichuan Cancer Hospital
Chengdu, China
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16
West China Hospital, Sichuan University
Chengdu, China
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17
Chifeng Municipal Hospital
Chifeng, China
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18
Army Medical Center of PLA
Chongqing, China
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19
Chongqing University Cancer Hospital
Chongqing, China
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20
China-Japan Union Hospitai Of Jilin University
Ch’ang-ch’un, China
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21
The First Affiliated Hospital of Dalian Medical University
Dalian, China
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22
Fujian Cancer Hospital
Fuzhou, China
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23
Fuzhou Pulmonary Hospital of Fujian
Fuzhou, China
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24
The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
Fuzhou, China
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25
First Affiliated Hospital Of Gannan Medical University
Ganzhou, China
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26
Guangdong Province Traditional Chinese Medical Hospital
Guangzhou, China
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27
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
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28
The Frist Affiliated Hospital of Guangzhou Medical College
Guangzhou, China
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29
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, China
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30
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, China
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31
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, China
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32
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
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33
Zhejiang Cancer Hospital
Hangzhou, China
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34
Hanzhong Central Hospital
Hanzhong, China
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35
Harbin Medical University Cancer Hospital
Harbin, China
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36
Cancer Hospital affiliated to Harbin Medical University
Ha’erbin, China
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37
Harbin Medical University cancer hospital
Ha’erbin, China
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38
The Second Hospital of Anhui Medical University
Hefei, China
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39
Henan Cancer Hospital (Affiliated Cancer Hospital of Zhengzhou University)
Henan, China
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40
Inner Mongolia People's Hospital
Hohhot, China
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41
Jiangxi cancer hospital
Jiangxi, China
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42
The First Hospital of Jilin University
Jilin, China
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43
Shandong Cancer Hospital & institute
Jinan, China
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44
Yunnan Cancer Hospital
Kunming, China
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45
The First Hospital of Lanzhou University
Lanzhou, China
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46
Jiangxi Cancer Hospital
Nanchang, China
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47
General Hospital of Eastern Theater Command
Nanjing, China
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48
Jiangsu Cancer Hospital
Nanjing, China
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49
Jiangsu Province Hospital
Nanjing, China
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50
Nanjing Drum Tower Hospital
Nanjing, China
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51
Guangxi Medical University Cancer Center
Nanning, China
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52
Nantong Tumor Hospital
Nantong, China
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53
Qingdao Central Hospital
Qingdao, China
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54
The Affiliated Hospital of Qingdao University
Qingdao, China
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55
First Hospital of Qinhuangdao
Qinhuangdao, China
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56
ShangHai Chest Hospital
Shanghai, China
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57
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, China
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58
Cancer Hospital of Shantou University Medical College
Shantou, China
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59
Liaoning Cancer Hospital & Institute
Shenyang, China
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60
Liaoning Cancer Hospital
Shenyang, China
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61
The First Hospital of China Medical University
Shenyang, China
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62
Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital
Shenzhen, China
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63
Shenzhen People's Hospital
Shenzhen, China
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64
The First Affiliated Hospital of Soochow University
Suzhou, China
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65
Shanxi Provincial Cancer Hospital
Taiyuan, China
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66
Taizhou Hospital of Zhejiang Province
Taizhou, China
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67
General Hospital of Tianjin Medical University
Tianjin, China
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68
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
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69
Tonghua Central Hospital
Tonghua, China
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70
Weifang People's Hospital
Weifang, China
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71
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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72
Hubei Cancer Hospital
Wuhan, China
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73
Renmin Hospital of Wuhan University/Hubei General Hospital
Wuhan, China
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74
Union Hospital, Tongji Medical College Huazhong University of Science and Technolog
Wuhan, China
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75
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
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76
Zhongnan Hospital Affiliated to Wuhan University
Wuhan, China
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77
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
Wuhu, China
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78
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Actively Recruiting
79
The First Affiliated Hospital Of Xiamen University
Xiamen, China
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80
Xuzhou Central Hospital
Xuzhou, China
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81
Yantai Yuhuangding Hospital
Yantai, China
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82
The No. 2 People's Hospital of Yibin Sichuan
Yibin, China
Actively Recruiting
83
Hospital of Ningxia Medical University
Yinchuan, China
Actively Recruiting
84
He Nan Cancer Hospital
Zhengzhou, China
Actively Recruiting
85
Henan Provincial People's Hospital
Zhengzhou, China
Actively Recruiting
86
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
87
Henan Provincial People's Hospital
Zhenzhou, China
Actively Recruiting
Research Team
W
Wanlin Chen, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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