Ignite Creation Date:
2024-05-06 @ 3:33 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04671875
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-12-11
Brief Title:
A Clinical Study of MIL93 in Solid Tumors
Sponsor:
Beijing Mabworks Biotech Co Ltd
Organization:
Beijing Mabworks Biotech Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate Safety Tolerability Pharmacokinetics and Efficacy of MIL93 in Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
MIL93 is a recombinant humanized anti-Claudin 182 CLDN182 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
Detailed Description:
This study is composed of two stagesPart 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 031 3 10 20 30 mgkg every 3 weeks Q3W An accelerated titration followed by traditional 33 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 weeksQ2W 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 1Subjects with untreated CLDN182 positive gastricgastroesophageal junction adenocarcinomaGGEJAC will be treated with MIL93 and standard first-line chemotherapyCohort 2Subjects with untreated CLDN182 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy
The dose escalation study will be conducted using Part I for testing optimal doses at 031 3 10 20 30 mgkg every 3 weeks Q3W An accelerated titration followed by traditional 33 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 weeksQ2W 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 1Subjects with untreated CLDN182 positive gastricgastroesophageal junction adenocarcinomaGGEJAC will be treated with MIL93 and standard first-line chemotherapyCohort 2Subjects with untreated CLDN182 positive pancreatic cancer will be treated with MIL93 and standard first-line chemotherapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None