Advanced Unresectable Solid Tumors
Conditions
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 With Advanced Unresectable Solid Tumors in China.
Interventions
DRUGM108
Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles)
Sponsors
FutureGen Biopharmaceutical (Beijing) Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent. 2. Advanced Unresectable solid tumors proven by histology 3. At least 1 measurable site of the disease according RECIST 1.1 criteria 4. ECOG performance status (PS) 0-1 5. Life expectancy \> 3 months 6. Age ≥ 18 years and ≤75 years 7. 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. 8. 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. 9. Adequate hepatic function; bilirubin ≤1.5 x ULN, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤2.5 x ULN. 10. Adequate renal function; creatinine ≤1.5 x ULN, or reatinine clearance rate ≥60 mL/minute calculated.
Exclusion criteria
1. 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; 2. 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). 3. Previous anti-tumor therapy within 4 weeks prior to the start of study treatment. 4. Previous major operation within 8 weeks prior to the start of study treatment. 5. Prior severe allergic reaction or intolerance to a monoclonal antibody, including humanised or chimeric antibodies. 6. Symptomatic cerebral metastases. 7. Uncontrolled or severe illness. 8. Known human immunodeficiency virus infection or known symptomatic hepatitis 9. Other clinically significant disease which may have adversely affected the safe delivery of treatment within this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | From enrollment until 28+7 days after the last dose | defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0) |
| Maximum Tolerated Dose | 21 days | MTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum measured plasma concentration of M108 | From enrollment until 28 days after the last dose | Cmax |
| Time to maximum plasma concentration of M108 | From enrollment until 28 days after the last dose | Tmax |
| Half-life of M108 | From enrollment until 28 days after the last dose | T1/2 |
| Immunogenicity profile of M108 | From enrollment until 28 days after the last dose | Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA). |
| Objective Response Rate | From first dose to disease progression , death or end of study，an average of 1 year | ORR |
| Progression free survival | From first dose to disease progression , death or end of study，an average of 1 year | PFS |
Countries
China
Contacts
Primary ContactZhaoyu Jin, Ph.D
Outcome results
None listed