A Clinical Study of MIL95 in Advanced Malignancies.

  • STATUS
    Recruiting
  • End date
    Nov 17, 2023
  • participants needed
    58
  • sponsor
    Beijing Mabworks Biotech Co., Ltd.
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Updated on 4 October 2022
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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.

Details
Condition Advanced Malignancies
Treatment Recombinant Humanized Monoclonal Antibody MIL95
Clinical Study IdentifierNCT04651348
SponsorBeijing Mabworks Biotech Co., Ltd.
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion 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

Exclusion Criteria

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 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
Clear my responses
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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