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New treatment option for Advanced Malignancies
Official title A Clinical Study of MIL95 in Advanced Malignancies.
ClinicalTrials.gov ID: NCT04651348
What this study is testing
What is Recombinant Humanized Monoclonal Antibody MIL95?
Recombinant Humanized Monoclonal Antibody MIL95 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced malignancies.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult patients, \>=18 years of age;
- Diagnosis of Refractory/relapsed lymphomas or solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy \>=3 months;
- Sufficient organ and bone marrow function;
You likely can't join if
- Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
- Previous exposure to any drug targeting CD47 or SIRPα;
- Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
- Central nervous system metastasis;
- History of other primary malignant tumors in 5 years;
See the full eligibility criteria
- Adult patients, \>=18 years of age;
- Diagnosis of Refractory/relapsed lymphomas or solid tumor;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy \>=3 months;
- Sufficient organ and bone marrow function;
- At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014);
- Able and willing to provide written informed consent and to comply with the study protocol.
- Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start;
- Previous exposure to any drug targeting CD47 or SIRPα;
- Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
- Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period;
- Central nervous system metastasis;
- History of other primary malignant tumors in 5 years;
- Evidence of significant, uncontrolled concomitant disease;
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA );
- Active or suspected autoimmune diseases;
- 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...
- Known history of hemolytic anemia;
- Known severe allergic reaction or/and infusion reaction to monoclonal antibody.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.