Clinical Trials /

A Phase I Study of MSB2311 in Advanced Solid Tumors

NCT03463473

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Phase I Study of MSB2311 in Advanced Solid Tumors
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MSB2311-CSP-001
  • NCT ID: NCT03463473

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
MSB2311 InjectionMSB2311MSB2311 Injection

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
MSB2311 InjectionExperimentalMSB2311 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.
  • MSB2311 Injection

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Safety and tolerability of MSB2311
Time Frame:Up to 90 days following the last dose
Safety Issue:
Description:Measured by number adverse events that are related to treatment

Secondary Outcome Measures

Measure:Area under the plasma concentration versus time curve (AUC) for MSB2311
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Peak Plasma concentration (Cmax)for MSB2311
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:Incidence and quantity of anti-drug antibodies
Measure:Volume of plasma from which MSB2311 is completely removed per unit time (CL)
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:The incidence of subjects generating anti-drug antibody
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Objective response rate (ORR) as measured by RESISTv1.1
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Duration of response (DOR) as measured by RESISTv1.1
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Progression-free survival (PFS) as measured by RESISTv1.1
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Best overall response as measured by RESISTv1.1
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure:Overall survival (OS) as measured by RESISTv1.1
Time Frame:Up to 30 days following the last dose
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Mabspace Biosciences (Suzhou) Co., Ltd.

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