Status:
COMPLETED
A Phase I Study of MSB2311 in Advanced Solid Tumors
Lead Sponsor:
Suzhou Transcenta Therapeutics Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 advanc...
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 enr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03463473
Start Date
April 12 2018
End Date
June 1 2020
Last Update
December 18 2023
Active Locations (1)
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1
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States, 78229