Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515990
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
A Study of DM005 in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Multicenter Open-label First-in-human Dose Escalation and Expansion Study of DM005 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to find out about the safety efficacy and tolerability of DM005 for patients with the advanced solid tumors DM005 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors For each participant there will be a screening period of up to 28 days a treatment period consisting of 21-day cycles an end of treatment EOT Visit 7 days and a Follow-up Visit at 30 days 7 days after the EOT Visit
Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle every 3 weeks Q3W An initial dose of DM005 will be infused intravenously IV into each participant for approximately 60 minutes 10 on Cycle1 Day 1 If there is no infusion-related reaction IRR during or after the initial dose with the Investigators confirmation and supervision the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes 5 A 21-day observation period Cycle 1 will then occur at the end of which all relevant safety data will be reviewed
Participants with advanced solid malignant tumors will be treated with DM005 on Day 1 of each cycle every 3 weeks Q3W An initial dose of DM005 will be infused intravenously IV into each participant for approximately 60 minutes 10 on Cycle1 Day 1 If there is no infusion-related reaction IRR during or after the initial dose with the Investigators confirmation and supervision the subsequent dosing of DM005 in the following cycles maybe infused IV for approximately 30 minutes 5 A 21-day observation period Cycle 1 will then occur at the end of which all relevant safety data will be reviewed
Detailed Description:
This first-in-human FIH multicenter open-label dose escalation and dose expansion study is to evaluate the safety preliminary efficacy and pharmacokinetic PK characteristics of DM005 monotherapy in participants with advanced solid tumors
DM005 a bispecific ADC developed using fully human antibodies with a common light chain which targets c-MET and EGFR
Subjects with solid malignant tumors will be treated with DM005 on Day 1 once Q3W dose adjustments may be required depending on the safety profile and PK data of each dose
DM005 a bispecific ADC developed using fully human antibodies with a common light chain which targets c-MET and EGFR
Subjects with solid malignant tumors will be treated with DM005 on Day 1 once Q3W dose adjustments may be required depending on the safety profile and PK data of each dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None