Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514651
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-20
Brief Title:
MAQ-001 in Patients With Advanced Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IAIB Study to Investigate the Safety Tolerability and Pharmacokinetic Characteristics of Intravenous IV MAQ-001 as Monotherapy and Combination Immunotherapy in Patients With Advanced Solid Tumors
Status:
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 interventional study is to test a new monoclonal antibody called MAQ-001 as a potential treatment for certain types of advanced cancers in different organs or compartments such as skin lung kidney liver stomach bowel the female reproductive system and hematology lymph node cancers The main questions it aims to answer are
the best dose of MAQ-001 that is safe to use alone or in combination with another anti-cancer medicine ipilimumab
how MAQ-001 works in the body and how it affects the whole cancer and its cells
Participants will
receive a defined dose of MAQ-001 or MAQ-001 in combination with ipilimumab depending on rank of enrolment on day 1 of a 21-day cycle for a maximum of 2 years
receive safety examinations and tumor assessment
donate blood and other biological materials for safety and pharmacokinetic evaluation
the best dose of MAQ-001 that is safe to use alone or in combination with another anti-cancer medicine ipilimumab
how MAQ-001 works in the body and how it affects the whole cancer and its cells
Participants will
receive a defined dose of MAQ-001 or MAQ-001 in combination with ipilimumab depending on rank of enrolment on day 1 of a 21-day cycle for a maximum of 2 years
receive safety examinations and tumor assessment
donate blood and other biological materials for safety and pharmacokinetic evaluation
Detailed Description:
None
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