A Clinical Study of MIL95 in Advanced Malignancies.

Beijing Mabworks Biotech

Status and phase: Enrolling; Phase 1

Conditions: Advanced Malignancies

Treatments: Drug: Recombinant Humanized Monoclonal Antibody MIL95

Study type: Interventional

Funder types: Industry

Identifiers

NCT04651348

MIL95-CT101

Details and patient eligibility

About

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.

The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days.

Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.

Enrollment: 58 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

58 participants in 1 patient group

MIL95

Experimental group

Treatment:

Drug: Recombinant Humanized Monoclonal Antibody MIL95