NCT04671875

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
228

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2021

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 21, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

March 13, 2024

Status Verified

December 1, 2023

Enrollment Period

4.3 years

First QC Date

December 11, 2020

Last Update Submit

March 11, 2024

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with Adverse Events

    Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.

    up to 1year after enrollment

Secondary Outcomes (6)

  • Pharmacokinetics:AUC

    up to 1year after enrollment

  • Pharmacokinetics: Cmax

    up to 1year after enrollment

  • Objective response rate (ORR)

    up to 1year after enrollment

  • Duration of response (DoR)

    up to 1year after enrollment

  • Progression free survival (PFS)

    up to 1year after enrollment

  • +1 more secondary outcomes

Study Arms (1)

MIL93

EXPERIMENTAL
Drug: Recombinant Humanized Monoclonal Antibody MIL93

Interventions

Recombinant Humanized Monoclonal Antibody MIL93DRUG

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.

MIL93

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients, \>=18 years of age;
  • 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.
  • 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);
  • Able and willing to provide written informed consent and to comply with the study protocol.

You may not qualify if:

  • 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 CLDN 18.2;
  • Major surgery within 8 weeks prior to the first administration or expected to undergo major surgery during the study treatment;
  • Systemic immunosuppressive therapy was required within 14 days prior to the first administration;
  • 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 );
  • Suffering from serious or uncontrollable gastro-intestinal tract bleed;
  • Known severe allergic reaction or/and infusion reaction to monoclonal antibody;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

RECRUITING

Central Study Contacts

Jing Huang, doctor

CONTACT

(+86)010-87788293huangjingwg@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 17, 2020

Study Start

April 21, 2021

Primary Completion

August 1, 2025

Study Completion

August 1, 2025

Last Updated

March 13, 2024

Record last verified: 2023-12

Locations

CN(1)