Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04651348

A Clinical Study of MIL95 in Advanced Malignancies.

Led by Beijing Mabworks Biotech Co., Ltd. · Updated on 2024-11-20

58

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

A Clinical Study of MIL95 in Advanced Malignancies.

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients, 60;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 60;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
Not Eligible

You will not qualify if you...

  • 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 SIRPB1
  • 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 this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments
  • Known history of hemolytic anemia
  • Known severe allergic reaction or/and infusion reaction to monoclonal antibody

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Cancer Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yuqin Song, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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