A Clinical Study of MIL93 in Solid Tumors.

Launched by BEIJING MABWORKS BIOTECH CO., LTD. · Dec 11, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MIL93, which is a special type of medication designed to target certain cancer cells in patients with advanced solid tumors. The trial aims to understand how safe and effective MIL93 is for people whose cancer cannot be treated with standard therapies, and it is currently looking for participants. To be eligible, patients must be at least 18 years old and have a confirmed diagnosis of advanced cancer that expresses a specific protein called CLDN18.2. This includes those who haven't received other treatments recently or have tumors that meet certain criteria.

Participants in this study can expect to receive MIL93 either alone or in combination with other treatments, depending on their specific cancer type. The trial will monitor their health closely to assess how well the drug works and to identify any side effects. Additionally, participants should be in good overall health and have a life expectancy of at least three months. It's important to note that those with certain medical conditions or previous treatments may not be eligible for this study. If you or a loved one is interested in joining, it's essential to discuss this option with a healthcare provider for further guidance.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients, \>=18 years of age;
• 2. Suffer from advanced unresectable or metastatic malignant solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
• • Mono-therapy dose escalation study: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
• • Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (through immunohistochemistry (IHC) test) confirmed by the central laboratory at enrollment.
• • Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer.
• • 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 4. Life expectancy \>=3 months;
• • 5. Sufficient organ and bone marrow function;
• • 6. At least one measurable lesion or evaluable lesion (recist v1.1);
• • 7. Able and willing to provide written informed consent and to comply with the study protocol.
• Exclusion Criteria:
• • 1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
• • 2. Previous exposure to any drug targeting CLDN 18.2;
• • 3. Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
• • 4. Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
• • 5. Central nervous system metastasis;
• • 6. History of other primary malignant tumors in 5 years;
• • 7. Evidence of significant, uncontrolled concomitant disease;
• • 8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
• • 9. Suffering from serious or uncontrollable gastro-intestinal tract bleed;
• • 10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
• • 11. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 6 months after discontinuation of all study treatments.