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A Clinical Study of MIL93 in Solid Tumors.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04671875
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : March 17, 2023
Sponsor:
Information provided by (Responsible Party):
Beijing Mabworks Biotech Co., Ltd.

Study Description
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Brief Summary:
MIL93 is a recombinant humanized anti-Claudin 18.2 (CLDN18.2) IgG1 monoclonal antibody. This is an open label Phase I study to evaluate safety, tolerability, pharmacokinetics and efficacy of MIL93 in Advanced or Metastatic solid tumors.

Condition or disease Intervention/treatment Phase
Advanced Malignancies Drug: Recombinant Humanized Monoclonal Antibody MIL93 Phase 1

Detailed Description:

This study is composed of two stages:Part I is mono-therapy dose escalation and dose expansion study, and Part II is the study of combination therapy.

The dose escalation study will be conducted using Part I for testing optimal doses at 0.3,1, 3, 10, 20, 30 mg/kg every 3 weeks (Q3W). An accelerated titration followed by traditional 3+3 design will be used in this study with a 21-day dose-limiting toxicity (DLT) observation period. Based on the data of dose escalation study, determine whether to carry out dose escalation at frequency of every 2 weeks(Q2W) and how many cohorts will be added in dose expansion study.

Based on the data of Part I, one or two doses will be conducted in the study of combination therapy. The study of PART II is composed of two cohorts. Cohort 1:Subjects with untreated CLDN18.2 positive gastric/gastroesophageal junction adenocarcinoma(G/GEJAC) will be treated with MIL93 and standard first-line chemotherapy.Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors.
Actual Study Start Date : April 21, 2021
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : August 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: MIL93 Drug: Recombinant Humanized Monoclonal Antibody MIL93

PART I :The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg,respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL93 every 3 or 2 week on Day 1.

PART II:One recommended dose will be conducted from 6 dose groups based on results of PART I.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: up to 1year after enrollment ]
    Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.


Secondary Outcome Measures :
  1. Pharmacokinetics:AUC [ Time Frame: up to 1year after enrollment ]
    The area under the curve (AUC) of serum concentration of the drug after the administration

  2. Pharmacokinetics: Cmax [ Time Frame: up to 1year after enrollment ]
    Maximum concentration(Cmax) of the drug after administration

  3. Objective response rate (ORR) [ Time Frame: up to 1year after enrollment ]
    To evaluate preliminary anti-tumor activity of MIL93 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria.

  4. Duration of response (DoR) [ Time Frame: up to 1year after enrollment ]
    DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.

  5. Progression free survival (PFS) [ Time Frame: up to 1year after enrollment ]
    Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.

  6. Immunogenicity [ Time Frame: up to 1year after enrollment ]
    Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL93.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients, >=18 years of age;

  2. Suffer from advanced unresectable or metastatic malignant solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:

    Mono-therapy dose escalation study: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.

    Mono-therapy dose expansion study: The subjects with positive CDLN18.2 expression in tumor tissue (through immunohistochemistry (IHC) test) confirmed by the central laboratory at enrollment.

    Combination study is composed of 2 cohorts.Cohort 1:Subjects with untreated CLDN18.2 positive G/GEJAC; Cohort 2:Subjects with untreated CLDN18.2 positive pancreatic cancer.

  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);
  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 CLDN 18.2;
  3. Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
  4. Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
  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. Suffering from serious or uncontrollable gastro-intestinal tract bleed;
  10. Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
  11. 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 6 months after discontinuation of all study treatments.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04671875


Contacts
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Contact: Jing Huang, doctor (+86)010-87788293 huangjingwg@163.com

Locations
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China
Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College Recruiting
Beijing, China
Contact: Jing Huang, doctor    (+86)010-87788293    huangjingwg@163.com   
Sponsors and Collaborators
Beijing Mabworks Biotech Co., Ltd.
More Information
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Responsible Party: Beijing Mabworks Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04671875    
Other Study ID Numbers: MIL93-CT101
First Posted: December 17, 2020    Key Record Dates
Last Update Posted: March 17, 2023
Last Verified: March 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs