A Clinical Study of MIL95 in Advanced Malignancies.

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

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

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note