Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475937
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-06-07
Brief Title:
A Study of DM001 in Patients With Advanced Solid Tumors
Sponsor:
Xadcera Biopharmaceutical Suzhou Co Ltd
Organization:
Doma BiopharmaceuticalSuzhouCo Ltd
Study Overview
Official Title:
A Phase I Multicenter Open-label First-in-Human Dose Escalation and Expansion Study of DM001 in Patients With Advanced Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The goal of this clinical trial is to find out about the safety efficacy and tolerability of DM001 for patients with the advanced solid tumors DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors
Participants will have up to 17 visits during the studyThere will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles Participants will have 5 study visits during Cycle 1 3 visits during Cycles 2 and 3 and 1 visit during subsequent cycles Participants will have an End of Treatment visit 21 days 7 days after last dose of study drug and then a follow-up visit 30 days 7 days after the End of Treatment visit
Participants will have up to 17 visits during the studyThere will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles Participants will have 5 study visits during Cycle 1 3 visits during Cycles 2 and 3 and 1 visit during subsequent cycles Participants will have an End of Treatment visit 21 days 7 days after last dose of study drug and then a follow-up visit 30 days 7 days after the End of Treatment visit
Detailed Description:
This is a Phase 1 multicenter openlabel first-in-human FIH doseescalation and dose expansion study to evaluate the safety tolerability PK and preliminary efficacy of DM001 in subjects with advanced solid tumors
DM001 a bispecific ADC developed using fully human antibodies with a common light chain which targets TROP2 and EGFR
DM001 is sterile yellowish-green lyophilized powder for IV infusion
Subjects with solid malignant tumors will be treated with DM001 on Day 1 once Q3W dose adjustments may be required depending on the safety profile and PK data of each dose
DM001 a bispecific ADC developed using fully human antibodies with a common light chain which targets TROP2 and EGFR
DM001 is sterile yellowish-green lyophilized powder for IV infusion
Subjects with solid malignant tumors will be treated with DM001 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?:
True
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