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Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03842085
Recruitment Status : Unknown
Verified June 2019 by Beijing Mabworks Biotech Co., Ltd..
Recruitment status was:  Recruiting
First Posted : February 15, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Beijing Mabworks Biotech Co., Ltd.

Brief Summary:
This is a phase I study evaluatingthesafetyand pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors.

Condition or disease Intervention/treatment Phase
HER2-positive Recurrent or Metastatic Malignant Solid Tumor Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301 Phase 1

Detailed Description:
This is an open-labeled phase I clinical study on MBS301 in treatment of patients with HER2 positive recurrent or metastatic malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists. The study will include a dose escalation period followed by an expansion period.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation on the Safety and Pharmacokinetics of Recombinant Humanized Bispecific Monoclonal Antibody MBS301 for Injection in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MBS301
Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301
Drug: Recombinant Humanized Bispecific Monoclonal Antibody MBS301
The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (2mg/kg, 6mg/kg, 10mg/kg,15mg/kg, and 20 mg/kg, respectively) based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patientwill be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated.
Other Name: MBS301




Primary Outcome Measures :
  1. DLT of MBS301 [ Time Frame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days) ]
    Evaluate the safety of MBS301, and determine the dose limited toxicity (DLT) .

  2. MTD of MBS301 [ Time Frame: up to the third treatment cycle of the last subject was ended (each cycle is 21 days) ]
    Evaluate the safety of MBS301, and determine the maximum tolerated dose (MTD).


Secondary Outcome Measures :
  1. Investigate the pharmacokinetics profile(Cmax) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Maximum Plasma Concentration [Cmax]

  2. Investigate the pharmacokinetics profile(AUC) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Area Under the Curve [AUC]

  3. Investigate the pharmacokinetics profile(Tmax) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Time for Peak concentration[Tmax]

  4. Investigate the pharmacokinetics profile(MRT) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Mean ResidenceTime[MRT]

  5. Investigate the pharmacokinetics profile(T1/2) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Half-life[T1/2]

  6. Investigate the pharmacokinetics profile(Vd) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Apparent volume of distribution[Vd]

  7. Investigate the pharmacokinetics profile(CL) of MBS301 [ Time Frame: At the end of Cycle 3 (each cycle is 21 days) ]
    Clearance[CL]

  8. Evaluate the immunogenicity of MBS301 [ Time Frame: screening, before the second/third cycle of administration, Cycle 1 day 15, at the end of Cycle 3 (each cycle is 21 days) ]
    Anti-drug antibody (ADA)

  9. Evaluate the objective response rate (ORR)of MBS301 [ Time Frame: up to approximately 2 years ]
    objective response rate (ORR)

  10. Evaluate the duration of response (DoR) of MBS301 [ Time Frame: up to approximately 2 years ]
    duration of response (DoR)

  11. Evaluate the disease control rate (DCR) of MBS301 [ Time Frame: up to approximately 2 years ]
    disease control rate (DCR)

  12. Evaluate the progression free survival (PFS) of MBS301 [ Time Frame: up to approximately 2 years ]
    progression free survival (PFS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with HER2-positive recurrent or metastatic malignant solid tumor,preferably the following tumors: breast cancer and stomach cancer,etc. diagnosed by histopathology or cytology. HER2-positive including IHC (+++) or ISH positive, IHC (++) should further carry out in situ hybridization (ISH) detection positive.
  • Patients with any types of malignant solid tumors who have progressed despite standard therapy or are intolerant of standard therapy, or for which no standard therapy exists.
  • Patients should have measurable lesions or immeasurable lesions (according to RECIST 1.1).
  • ECOG physical condition: 0 or 1 point.
  • Expected survival period exceeds 12 weeks.

Exclusion Criteria:

  • Absolute neutrophils count (ANC) is less than1.5×109/L and/or blood platelets less than 100 ×109/L and/or hemoglobin less than 10g/dL.
  • Total bilirubin is more than 1.5 ×ULN.
  • Patients without hepatic metastasis, ALT or AST is more than 1.5 ×ULN; Patients with hepatic metastasis, ALT or AST is more than 5 ×ULN.
  • Serum creatinine is more than 1.5 × ULN or estimated creatinine clearance <50 mL/min(according to Cockcroft-Gault).
  • International normalized ratio (INR) is more than 1.5 × ULN or activated partial thromboplastin time (APTT) is more than 1.5 × ULN.
  • Patient had surgery or anti-tumor treatmentswithin4 weeks prior to the study treatment, including chemotherapy or radiotherapy or immunotherapy or Trastuzumab;Patient was treated withnitrosourea or mitomycinwithin6 weeks prior to the study treatment, andtreated with endocrinotherapy within2 weeks prior to the study treatment.
  • Patient has prior treated with anthracyclineswhich accumulated dose is equivalent to adriamycin≥360mg/m2.
  • Patient has been experienced toxic reactions after previous anticancer therapy and has not recovered to Grade 0 or Grade 1 (except for hair loss).
  • Known a history with brain metastasis.
  • Patients with interstitial pneumonia, dyspnea at rest or requiring oxygen therapy due to malignant tumor complications or merger disease, ARDS, pleural effusion requiring drainage, or other serious lung diseases determined by the investigator.
  • Suffer from other malignant tumors previously or currently (except for Phase IB or lower cervical cancer, non-invasive basal cell or squamous cell skin cancer that has been cured; malignant melanoma with complete remission (CR) >10 years and other malignant tumors with complete remission (CR) >5 years).
  • Suffer from active infection requiring intravenous infusion of antibiotics, mental disease and other serious non-malignant diseases (such as clinically significant valvular heart disease), congestive heart failure;Angina pectoris requiring medication, myocardial infarction or stroke within 6 months, refractory arrhythmia, left ventricular ejection fraction (LVEF)<50% (or below the lower limit of normal value of ultrasonic cardiogram) in previous trastuzumab therapy, poorly controlled hypertension (systolic pressure> 180 mm Hg or diastolic pressure > 100 mm Hg), and poorly controlled diabetes.
  • Have a history of liver disease of clinical significance.
  • Known to be human immunodeficiency virus (HIV) positive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03842085


Contacts
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Contact: lin danhua, MD 008615811460241 lindh@mab-works.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200000
Contact: Hu Xichun, MD       xchu2009@hotmail.com   
Sponsors and Collaborators
Beijing Mabworks Biotech Co., Ltd.
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Responsible Party: Beijing Mabworks Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT03842085    
Other Study ID Numbers: MBS301-CT01
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Mabworks Biotech Co., Ltd.:
HER2-positive
solid tumor
MBS301
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Monoclonal
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs