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

Primary Purpose

Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MCLA-129
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged ≥ 18, regardless of gender.
  • Subjects with histologically or cytologically confirmed diagnosis of metastatic or unresectable advanced NSCLC or other solid tumors (including but not limited to head and neck cancer, colorectal, etc.) who have disease progression on, or were not resistant to, or reject the standard treatment.
  • For Part 1, subjects must be diagnosed with EGFR positive and/or MET positive after testing.
  • For Part 2, patients need to undergo the centralized biomarker testing.
  • Subjects of the dose escalation phase in Part 1 must have evaluable diseases, and others must have measurable diseases as defined in RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-1.
  • Expected survival is ≥3 months.
  • With certain organ system functions (without transfusion, use of blood components, or G-CSF support within 14 days before testing), as defined below:

    • Absolute Neutrophil Count (ANC) ≥1.5×10^9 /L
    • Platelet count (PLT)≥75×10^9 /L
    • Hemoglobin (HB) ≥10 g/dL
    • 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 is ≥50 mL/min as calculated by Cockcroft-Gault formula, or ≥50 mL/min within 24 h as measured, the patients can still be included.
  • Willing to and capable of following the trial and follow-up schedule.
  • Capable of understanding the trial nature and voluntarily signing the written informed consent form.
  • The subjects of Part 2 must agree that the tumor tissue samples before treatment of the investigational drug can be collected or provided.

Exclusion Criteria:

  • Use of certain investigational drug or antineoplastic agent within 14 days before first administration of MCLA-129 or within 5 half lives (whichever is longer).
  • Execution of large surgery and radiotherapy (except focal palliative radiotherapy at least 2 weeks before first administration), immunotherapy, chemotherapy (for Nitrosoureas or Mitomycin C and other chemotherapeutics with delayed toxicity, it shall be 6 weeks before first administration) within 4 weeks before first administration of MCLA-129.
  • Patients with colorectal who are diagnosed with AS or BRAF gene mutation through testing.
  • Subjects with NSCLC who previously received more than 2 lines of cytotoxicity chemotherapy for treatment of focal advanced or metastatic disease (excluding maintenance therapy).
  • Subjects who previously received EGFR-TKI (e.g. Poziotinib or TAK-788) that is known to be effective to exon 20 insertion mutation
  • Prior use of EGFR/c-Met bispecific antibody drugs.
  • Response of toxic reactions related to prior therapy (except alopecia) not up to Grade 1 or below (CTCAE 5.0 criteria) before first administration of MCLA-129.
  • With other malignant tumors in the past 3 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, carcinoma cervix in situ, or in situ breast carcinoma.
  • 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.
  • With clinically significant cardiovascular disorder, including but not limited to:

    • Deep vein thrombosis or lung embolism diagnosed within 1 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.
    • 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. Re-measurement is made twice at an interval of 4 h above. 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.
    • 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.
    • With clinically significant cardiovascular disorder as believed by other investigators.
  • Active hepatitis B (hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, and serum HBV DNA ≥ 2000 IU/mL (equal to 104 copies/mL)), hepatitis C virus antibody, HIV antibody and treponema pallidum antibody positive.
  • Patients with Interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonitis.
  • Current severe disease or medical condition, including but not limited to uncontrolled active infection, and clinically significant lung, metabolic or psychiatric disorders.
  • Women with child bearing potential, pregnant women or lactating women with pregnancy test positive 7 days before treatment, and male and female unwilling to take effective contraception measures or having a birth plan during the treatment and within 3 months after end of treatment.
  • Patients who are known to have allergic reactions and hypersensitivity reactions, or be allergic to MCLA-129 or any other excipients.
  • Patients poorly compliant, unable or unwilling to follow the study and/or follow-up procedure listed in the protocol, or patients unsuitable to participate in this trial in the investigator's opinion.

Sites / Locations

  • Affiliated Hospital of Hebei University
  • Beijing Cancer Hospital
  • Cancer Institute and Hospital, Chinese Academy of Medical SciencesRecruiting
  • Peking University International Hospital
  • The Fifth Medical Center of PLA Ceneral Hospital
  • The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
  • Cangzhou Hospital of Integrated TCM-WM·Hebei
  • China-Japan Union Hospitai Of Jilin University
  • Ji Lin Cancer Hospital
  • Hunan Cancer Hospital
  • The Second Xiangya Hospital of Central South University
  • Sichuan Cancer Hospital
  • West China Hospital, Sichuan University
  • Chifeng Municipal Hospital
  • Army Medical Center of PLA
  • Chongqing University Cancer Hospital
  • Fujian Cancer Hospital
  • Fuzhou Pulmonary Hospital of Fujian
  • First Affiliated Hospital Of Gannan Medical University
  • Guangdong Province Traditional Chinese Medical Hospital
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  • The Frist Affiliated Hospital of GUANGZHOU Medical College
  • Cancer Hospital affiliated to Harbin Medical University
  • Cancer Hospital of The University of Chinese Academy of SciencesRecruiting
  • The First Affiliated Hospital, Zhejiang University
  • Hanzhong Central Hospital
  • The Second Hospital of Anhui Medical University
  • Inner Mongolia People's Hospital
  • Shandong Cancer Hospital & institute
  • Yunnan Cancer Hospital
  • The First Hospital of Lanzhou University
  • General Hospital of Eastern Theater Command
  • Jiangsu Cancer Hospital
  • Nanjing Drum Tower Hospital
  • Nantong Tumor Hospital
  • Qingdao Central Hospital
  • The Affiliated Hospital of Qingdao UniversityRecruiting
  • First Hospital of Qinhuangdao
  • ShangHai Chest Hospital
  • Liaoning Cancer Hospital&Institute
  • The First Hospital of China Medical University
  • Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital
  • Shenzhen People's Hospital
  • The First Affiliated Hospital of Soochow University
  • Shanxi Provincial Cancer Hospital
  • Taizhou Hospital of Zhejiang Province
  • General Hospital of Tianjin Medical University
  • Tianjin Medical University Cancer Institute & Hospital
  • Tonghua Central Hospital
  • Weifang People's Hospital
  • The First Affiliated Hospital of Wenzhou Medical University
  • Renmin Hospital of Wuhan University/Hubei General Hospital
  • Union Hospital, Tongji Medical College Huazhong University of Science and TechnologRecruiting
  • Zhongnan Hospital Affiliated to Wuhan University
  • The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
  • The First Affiliated Hospital of Xi'an Jiaotong University
  • The First Affiliated Hospital Of Ximen University
  • Xuzhou Central Hospital
  • Yantai Yuhuangding Hospital
  • The No. 2 People's Hospital of Yibin Sichuan
  • Hospital of Ningxia Medical University
  • He Nan Cancer Hospital
  • Henan Provincial People's Hospital
  • The First Affiliated Hospital of Zhengzhou University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MCLA-129

Arm Description

In the dose escalation phase 1 part, MCLA-129 will be administered every two weeks with increasing doses to patients with advanced solid tumors. In Part 2, patients with NSCLC and other advanced solid tumors in each corhort will be dosed with MCLA-129 every two weeks at the RP2D.

Outcomes

Primary Outcome Measures

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.
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.
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 corhort in Part 2 in terms of overall response rate (ORR)
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)

Secondary Outcome Measures

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)
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]
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]
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]
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]
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-∞]
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)
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)
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)
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)
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)
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
Cytokine TNF-α in Part 1
To assess the changes in TNF-α in serum blood following administration of MCLA-129
Cytokine IFN-γ in Part 1
To assess the changes in IFN-γ in serum blood following administration of MCLA-129
Cytokine IL-1β in Part 1
To assess the changes in IL-1β in serum blood following administration of MCLA-129
Cytokine IL-2 in Part 1
To assess the changes in IL-2 in serum blood following administration of MCLA-129
Cytokine IL-6 in Part 1
To assess the changes in IL-6 in serum blood following administration of MCLA-129
Cytokine IL-8 in Part 1
To assess the changes in IL-8、IL-10 in serum blood following administration of MCLA-129
Cytokine IL-10 in Part 1
To assess the changes in IL-10 in serum blood following administration of MCLA-129

Full Information

First Posted
May 31, 2021
Last Updated
December 19, 2021
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04930432
Brief Title
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor, Non-Small Cell Lung Cancer, Head and Neck Cancer, Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MCLA-129
Arm Type
Experimental
Arm Description
In the dose escalation phase 1 part, MCLA-129 will be administered every two weeks with increasing doses to patients with advanced solid tumors. In Part 2, patients with NSCLC and other advanced solid tumors in each corhort will be dosed with MCLA-129 every two weeks at the RP2D.
Intervention Type
Drug
Intervention Name(s)
MCLA-129
Intervention Description
MCLA-129 will be administered by intravenous infusion.
Primary Outcome Measure Information:
Title
Dose-Limiting Toxicity (DLT) in Part 1
Description
To determine the dose-limiting toxicity (DLT) of single agent MCLA-129 in patients with advanced solid tumors in Part 1.
Time Frame
First 28 days of treatment
Title
Maximum Tolerated Dose (MTD) in Part 1
Description
To determine the maximum tolerated dose (MTD) of single agent MCLA-129 in patients with advanced solid tumors in Part 1.
Time Frame
First 28 days of treatment
Title
Overall Response Rate (ORR) in Part 2
Description
To evaluate the efficacy of MCLA-129 at RP2D in patients with advanced NSCLC and other solid tumors in each corhort in Part 2 in terms of 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
Title
Treatment-Emergent Adverse Event (TEAE) in Part 1 and 2
Description
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)
Time Frame
Until 30 days after the last dosing
Secondary Outcome Measure Information:
Title
Half-life [t1/2] in Part 1 and 2
Description
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)
Time Frame
Until 30 days after the last dosing
Title
Apparent volume of distribution [VSS] in Part 1 and 2
Description
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]
Time Frame
Until 30 days after the last dosing
Title
Maximum plasma concentration [Cmax] in Part 1 and 2
Description
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]
Time Frame
Until 30 days after the last dosing
Title
Time to reach maximum concentration [Tmax] in Part 1 and 2
Description
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]
Time Frame
Until 30 days after the last dosing
Title
Area under the concentration versus time curve from time zero to time t [AUC0-t] in Part 1 and 2
Description
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]
Time Frame
Until 30 days after the last dosing
Title
Area under the concentration versus time curve [AUC0-∞] in Part 1 and 2
Description
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-∞]
Time Frame
Until 30 days after the last dosing
Title
Overall Response Rate (ORR) in Part 1
Description
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)
Time Frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Title
Disease Control Rate (DCR) in Part 1 and 2
Description
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)
Time Frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Title
Progression-Free Survival (PFS) in Part 1 and 2
Description
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)
Time Frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Title
Duration of Response (DOR) in Part 1 and 2
Description
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)
Time Frame
From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Title
Overall Survival (OS) in Part 1 and 2
Description
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)
Time Frame
From date of first treatment every 6 weeks until death or withdrawal, whichever came first, approximately 2 years
Title
Anti-Drug Antibody (ADA) in Part 1 and 2
Description
To assess the Incidence of anti-drug antibodies in serum blood against MCLA-129 following administration of MCLA-129
Time Frame
Until 30 days after the last dosing
Title
Cytokine TNF-α in Part 1
Description
To assess the changes in TNF-α in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IFN-γ in Part 1
Description
To assess the changes in IFN-γ in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IL-1β in Part 1
Description
To assess the changes in IL-1β in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IL-2 in Part 1
Description
To assess the changes in IL-2 in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IL-6 in Part 1
Description
To assess the changes in IL-6 in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IL-8 in Part 1
Description
To assess the changes in IL-8、IL-10 in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15
Title
Cytokine IL-10 in Part 1
Description
To assess the changes in IL-10 in serum blood following administration of MCLA-129
Time Frame
Before and after each administration on day 1 and day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged ≥ 18, regardless of gender. Subjects with histologically or cytologically confirmed diagnosis of metastatic or unresectable advanced NSCLC or other solid tumors (including but not limited to head and neck cancer, colorectal, etc.) who have disease progression on, or were not resistant to, or reject the standard treatment. For Part 1, subjects must be diagnosed with EGFR positive and/or MET positive after testing. For Part 2, patients need to undergo the centralized biomarker testing. Subjects of the dose escalation phase in Part 1 must have evaluable diseases, and others must have measurable diseases as defined in RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-1. Expected survival is ≥3 months. With certain organ system functions (without transfusion, use of blood components, or G-CSF support within 14 days before testing), as defined below: Absolute Neutrophil Count (ANC) ≥1.5×10^9 /L Platelet count (PLT)≥75×10^9 /L Hemoglobin (HB) ≥10 g/dL 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 is ≥50 mL/min as calculated by Cockcroft-Gault formula, or ≥50 mL/min within 24 h as measured, the patients can still be included. Willing to and capable of following the trial and follow-up schedule. Capable of understanding the trial nature and voluntarily signing the written informed consent form. The subjects of Part 2 must agree that the tumor tissue samples before treatment of the investigational drug can be collected or provided. Exclusion Criteria: Use of certain investigational drug or antineoplastic agent within 14 days before first administration of MCLA-129 or within 5 half lives (whichever is longer). Execution of large surgery and radiotherapy (except focal palliative radiotherapy at least 2 weeks before first administration), immunotherapy, chemotherapy (for Nitrosoureas or Mitomycin C and other chemotherapeutics with delayed toxicity, it shall be 6 weeks before first administration) within 4 weeks before first administration of MCLA-129. Patients with colorectal who are diagnosed with AS or BRAF gene mutation through testing. Subjects with NSCLC who previously received more than 2 lines of cytotoxicity chemotherapy for treatment of focal advanced or metastatic disease (excluding maintenance therapy). Subjects who previously received EGFR-TKI (e.g. Poziotinib or TAK-788) that is known to be effective to exon 20 insertion mutation Prior use of EGFR/c-Met bispecific antibody drugs. Response of toxic reactions related to prior therapy (except alopecia) not up to Grade 1 or below (CTCAE 5.0 criteria) before first administration of MCLA-129. With other malignant tumors in the past 3 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, carcinoma cervix in situ, or in situ breast carcinoma. 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. With clinically significant cardiovascular disorder, including but not limited to: Deep vein thrombosis or lung embolism diagnosed within 1 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. 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. Re-measurement is made twice at an interval of 4 h above. 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. 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. With clinically significant cardiovascular disorder as believed by other investigators. Active hepatitis B (hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, and serum HBV DNA ≥ 2000 IU/mL (equal to 104 copies/mL)), hepatitis C virus antibody, HIV antibody and treponema pallidum antibody positive. Patients with Interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonitis. Current severe disease or medical condition, including but not limited to uncontrolled active infection, and clinically significant lung, metabolic or psychiatric disorders. Women with child bearing potential, pregnant women or lactating women with pregnancy test positive 7 days before treatment, and male and female unwilling to take effective contraception measures or having a birth plan during the treatment and within 3 months after end of treatment. Patients who are known to have allergic reactions and hypersensitivity reactions, or be allergic to MCLA-129 or any other excipients. Patients poorly compliant, unable or unwilling to follow the study and/or follow-up procedure listed in the protocol, or patients unsuitable to participate in this trial in the investigator's opinion.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wanlin Chen, Master
Phone
18258270120
Email
wanlin.chen@bettapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Wang, PhD
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Beijing Cancer Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University International Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Fifth Medical Center of PLA Ceneral Hospital
City
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Bengbu Medical College
City
Bengbu
Country
China
Individual Site Status
Recruiting
Facility Name
Cangzhou Hospital of Integrated TCM-WM·Hebei
City
Cangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
China-Japan Union Hospitai Of Jilin University
City
Ch'ang-ch'un
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Ji Lin Cancer Hospital
City
Changchun
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hunan Cancer Hospital
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sichuan Cancer Hospital
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
West China Hospital, Sichuan University
City
Chengdu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chifeng Municipal Hospital
City
Chifeng
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Army Medical Center of PLA
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fujian Cancer Hospital
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Fuzhou Pulmonary Hospital of Fujian
City
Fuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
First Affiliated Hospital Of Gannan Medical University
City
Ganzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Guangdong Province Traditional Chinese Medical Hospital
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Frist Affiliated Hospital of GUANGZHOU Medical College
City
Guangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Cancer Hospital affiliated to Harbin Medical University
City
Ha'erbin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Cancer Hospital of The University of Chinese Academy of Sciences
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hanzhong Central Hospital
City
Hanzhong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Second Hospital of Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Inner Mongolia People's Hospital
City
Hohhot
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shandong Cancer Hospital & institute
City
Jinan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Yunnan Cancer Hospital
City
Kunming
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Nantong Tumor Hospital
City
Nantong
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Qingdao Central Hospital
City
Qingdao
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Name
First Hospital of Qinhuangdao
City
Qinhuangdao
Country
China
Individual Site Status
Not yet recruiting
Facility Name
ShangHai Chest Hospital
City
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Liaoning Cancer Hospital&Institute
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Hospital of China Medical University
City
Shenyang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Cancer Hospital of Chinese Academy of Medical Sciences Shenzhen Hospital
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shenzhen People's Hospital
City
Shenzhen
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Taizhou Hospital of Zhejiang Province
City
Taizhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Tonghua Central Hospital
City
Tonghua
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Weifang People's Hospital
City
Weifang
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Renmin Hospital of Wuhan University/Hubei General Hospital
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Union Hospital, Tongji Medical College Huazhong University of Science and Technolog
City
Wuhan
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongnan Hospital Affiliated to Wuhan University
City
Wuhan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital)
City
Wuhu
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital Of Ximen University
City
Xiamen
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Xuzhou Central Hospital
City
Xuzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The No. 2 People's Hospital of Yibin Sichuan
City
Yibin
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Hospital of Ningxia Medical University
City
Yinchuan
Country
China
Individual Site Status
Not yet recruiting
Facility Name
He Nan Cancer Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
Country
China
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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