A Clinical Study of MIL95 in Advanced Malignancies.

Launched by BEIJING MABWORKS BIOTECH CO., LTD. · Dec 2, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called MIL95 for patients with advanced cancers, including certain types of lymphomas and solid tumors that have not responded to previous therapies. The study is split into two parts. In the first part, researchers will gradually increase the dose of the treatment to find the highest dose that can be safely given without causing severe side effects. This process will involve monitoring patients for 14 days after receiving their dose. In the second part, the dose will be increased even further, with a longer observation period of 28 days for any side effects.

To participate, you must be an adult at least 18 years old, have a specific type of cancer that has not improved with other treatments, and be in fairly good health overall. You should also have measurable signs of your cancer for the researchers to track your response to the treatment. However, there are several criteria that could exclude you from participation, such as recent cancer therapies, certain health conditions, or active infections. If you qualify and choose to join, you will receive the new treatment and be closely monitored for any effects it may have on your health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients, \>=18 years of age;
• • 2. Diagnosis of Refractory/relapsed lymphomas or solid tumor;
• • 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 or Lugano 2014);
• • 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 CD47 or SIRPα;
• • 3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
• • 4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
• • 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. Active or suspected autoimmune diseases;
• • 10. 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 12 months after discontinuation of all study treatments;
• • 11. Known history of hemolytic anemia;
• • 12. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.