Clinical trial NCT04651348: A Clinical Study of MIL95 in Advanced Malignancies.
Official title: A Phase I Clinical Study of Recombinant Humanized Monoclonal Antibody MIL95 Injection in the Treatment of Lymphomas and Advanced Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Malignancies
Lead sponsor: Beijing Mabworks Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Percentage of Participants with Adverse Events
timeFrame: up to 1year after enrollment
Secondary outcomes:
measure: Pharmacokinetics:AUC
timeFrame: up to 1year after enrollment
measure: Pharmacokinetics: Cmax
timeFrame: up to 1year after enrollment
measure: Objective response rate (ORR)
timeFrame: up to 1year after enrollment
measure: Duration of response (DoR)
timeFrame: up to 1year after enrollment
measure: Progression free survival (PFS)
timeFrame: up to 1year after enrollment
measure: Immunogenicity
timeFrame: up to 1year after enrollment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
References: