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A Phase I Study of MSB2311 in Advanced Solid Tumors

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463473
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : May 14, 2019
Sponsor:
Information provided by (Responsible Party):
Mabspace Biosciences (Suzhou) Co., Ltd.

Brief Summary:
This is a phase I study to determine the safety and toxicity, PK/PD, immunogenicity, biomarkers, anti-tumor activity and establish a preliminary recommended Phase 2 dose (RP2D) in subjects with advanced solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: MSB2311 Injection Phase 1

Detailed Description:
This is a first-in-human (FIH), open-label, Phase 1 dose-Escalation Study of MSB2311, a humanized anti-PD-L1 monoclonal antibody, in subjects with advanced solid tumors. Qualified subjects will be enrolled to receive their assigned dose regimen of MSB2311 until disease progression or intolerable toxicity, withdrawal of consent, or end of study, whichever occurs first. The maximum treatment duration is 2 years. During the study, subjects will be evaluated for safety and toxicity, PK/PD, immunogenicity, biomarkers, and anti-tumor activity of MSB2311.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First-in-human, Open-label, Phase 1 Dose-Escalation Study of MSB2311, A Humanized Anti-PD-L1 Monoclonal Antibody in Subjects With Advanced Solid Tumors
Actual Study Start Date : April 12, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: MSB2311 Injection
MSB2311 will be administered as an IV infusion once every 3 weeks (Q3W). The planned doses starts at 0.3 mg/kg and may be escalted to 20 mg/kg, but dose levels or the dosing interval may be adjusted during the study based on emerging data.
Drug: MSB2311 Injection
An intravenous infusion with concentration from 0.3 mg/kg to 20 mg/kg every 3 weeks (Q3W).
Other Name: MSB2311




Primary Outcome Measures :
  1. Safety and tolerability of MSB2311 [ Time Frame: Up to 90 days following the last dose ]
    Measured by number adverse events that are related to treatment

  2. Maximum tolerated dose or recommended phase 2 dose [ Time Frame: Up to 90 days following the last dose ]
    Measured by number of subjects experiencing DLT in each escalation cohort


Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) for MSB2311 [ Time Frame: Up to 30 days following the last dose ]
  2. Peak Plasma concentration (Cmax)for MSB2311 [ Time Frame: Up to 30 days following the last dose ]
    Incidence and quantity of anti-drug antibodies

  3. Volume of plasma from which MSB2311 is completely removed per unit time (CL) [ Time Frame: Up to 30 days following the last dose ]
  4. The incidence of subjects generating anti-drug antibody [ Time Frame: Up to 30 days following the last dose ]
  5. Objective response rate (ORR) as measured by RESISTv1.1 [ Time Frame: Up to 30 days following the last dose ]
  6. Duration of response (DOR) as measured by RESISTv1.1 [ Time Frame: Up to 30 days following the last dose ]
  7. Progression-free survival (PFS) as measured by RESISTv1.1 [ Time Frame: Up to 30 days following the last dose ]
  8. Best overall response as measured by RESISTv1.1 [ Time Frame: Up to 30 days following the last dose ]
  9. Overall survival (OS) as measured by RESISTv1.1 [ Time Frame: Up to 30 days following the last dose ]
  10. Elimination half-life and apparent plasma terminal phase elimination rate constant (t1/2 ) of MSB2311 [ Time Frame: Up to 30 days following the last dose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Able to understand and willing to sign the ICF.
  • Male or female subject ≥ 18 years.
  • Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for which no standard therapy exists.
  • Subject has measurable disease per RECIST v1.1.
  • ECOG Performance Status 0 to 1
  • Subjects with life expectancy of ≥ 3 month
  • No herbal/alternative medications prior to the first dose
  • Must have adequate hematological, hepatic and renal function as defined in the protocol.
  • Prior anti-tumor therapies of different kinds must have stopped before the first dose as defined by protocol
  • Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

  • Pregnant or nursing females.
  • Any remaining AEs > grade 1 from prior anti-tumor treatment as per CTCAE v4. 03, with exception of the residual hair loss;
  • Received a biologic G-CSF, GM-CSF or erythropoietin within 14 days prior to the first dose of study drug;
  • Subjects who had prior treatment with an anti-PD-L1 product
  • History of documented autoimmune disease except for autoimmune hypothyroidism and well-controlled Type 1 diabetes mellitus.
  • W/o autoimmune condition requiring systemic treatment with immunosuppressive medications within 14 days before the planned first dose of study drug.
  • Primacy central nervous system (CNS) malignancy or symptomatic CNS metastases are not allowed, with exceptions defined in protocol.
  • Major surgery within the 28-days from the screening
  • Subjects with idiopathic pulmonary fibrosis or unresolved active or chronic inflammatory pulmonary disease are excluded.
  • History of human immunodeficiency virus (HIV) infection, active hepatitis B or C. HBV carriers
  • History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis disease.
  • Clinically significant acute infections 4 weeks and any infection 2 weeks prior to the first dose administration.
  • Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy
  • Subjects who experienced immunotherapy-related adverse events (irAE) grade ≥ 3, or who had to discontinue prior anti-PD-1 treatment due to irAEs of any grade.
  • Severe or uncontrolled cardiac disease requiring treatment as defined in protocol
  • Any other serious underlying medical, psychiatric, psychological, familial or geographical condition that, in the judgment of the investigator, might impair the subject's benefit from the trial treatment
  • Known history of hypersensitivity to any components of the MSB2311 product.

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): NCT03463473


Contacts
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Contact: Jenny(Zhen) Li +86-512-67079200 ext 8009 jenny.li@transcenta.com

Locations
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United States, Texas
South Texas Accelerated Research Therapeutics Recruiting
San Antonio, Texas, United States, 78229
Contact: Kyriakos P Papadopoulos, Dr.,MD.         
Sponsors and Collaborators
Mabspace Biosciences (Suzhou) Co., Ltd.
Investigators
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Study Director: Yonggang Wu, MD Mabspace Biosciences (Suzhou) Co., Ltd.

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Responsible Party: Mabspace Biosciences (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03463473    
Other Study ID Numbers: MSB2311-CSP-001
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms