Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

Launched by FUTUREGEN BIOPHARMACEUTICAL (BEIJING) CO., LTD · May 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called M108, which is a type of medication known as a monoclonal antibody. This treatment specifically targets certain types of stomach and esophagus cancers in patients with advanced solid tumors that cannot be surgically removed. The main goal of the study is to see how safe M108 is and how well it is tolerated by patients when given in different dosages. The trial is currently recruiting participants in China who are between 18 and 75 years old and have been diagnosed with advanced unresectable solid tumors.

To participate in this trial, individuals must provide written consent and have at least one measurable tumor that can be tracked during the study. They should also be in relatively good health, meaning their overall performance status is good and they have a life expectancy of more than three months. Participants can expect to be closely monitored for any side effects during the trial, and their health will be regularly assessed to ensure their safety. It's important to note that certain individuals, such as those who have had recent anti-cancer treatments or major surgeries, may not be eligible to join the study.

Gender

ALL

Eligibility criteria

• 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