Testing MIL95 for advanced cancers

A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors

This study is testing a new treatment called MIL95 to see if it can help people with advanced cancers feel better and improve their health.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing Mabworks Biotech Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT04651348 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the safety and efficacy of MIL95, a recombinant humanized monoclonal antibody, in patients with advanced malignancies. It consists of two parts: Part A focuses on dose escalation with four cohorts, while Part B continues with additional cohorts at higher doses. The study employs a classical 3+3 dose escalation design to determine the maximum tolerated dose and monitor for dose-limiting toxicities over specified observation periods.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with refractory or relapsed lymphomas or solid tumors and an ECOG performance status of 0 or 1.

Not a fit: Patients with central nervous system metastasis or those who have received anti-cancer therapy within four weeks prior to the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with refractory or relapsed advanced malignancies.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting advanced malignancies with monoclonal antibodies have shown promise.

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.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Yuqin Song, doctor

Conditions: Advanced Malignancies