Status:
UNKNOWN
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China
Lead Sponsor:
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Conditions:
Advanced Unresectable Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients W...
Eligibility Criteria
Inclusion
- Written informed consent.
- Advanced Unresectable solid tumors proven by histology
- At least 1 measurable site of the disease according RECIST 1.1 criteria
- ECOG performance status (PS) 0-1
- Life expectancy \> 3 months
- Age ≥ 18 years and ≤75 years
- Adequate haematological function; absolute neutrophil count ≥1.5 x 109/L; white blood cell count ≥3.0 x 109/L; platelets ≥100 x 109/L; haemoglobin ≥9 g/dL.
- Adequate coagulation function; international normalized ratio ( INR) ≤ 1.5 x upper limit of normal (ULN), or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN.
- Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN.
- Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.
Exclusion
- Previous received or planned to be vaccinated with 2019-nCoV vaccine or other vaccines within 3 months prior to the start of study treatment or during the study or within 3 months after the end of the study;
- Previous radiotherapy within 4 weeks prior to the start of study treatment. (if palliative radiotherapy was given to bone metastatic side peripherally and the patient recovered from acute toxicity was allowed).
- Previous anti-tumor therapy within 4 weeks prior to the start of study treatment.
- Previous major operation within 8 weeks prior to the start of study treatment.
- Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies.
- Symptomatic cerebral metastases.
- Uncontrolled or severe illness.
- Known human immunodeficiency virus infection or known symptomatic hepatitis
- Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study
Key Trial Info
Start Date :
June 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT04894825
Start Date
June 11 2021
End Date
December 30 2024
Last Update
November 27 2023
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142