Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-02-22 @ 11:36 AM
Study NCT ID:
NCT06514651
Status:
RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MAQ-001 in Patients With Advanced Solid Tumors
Sponsor:
MabQuest SA
Organization:
Study Overview
Official Title:
A Phase IA/IB 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:
False
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 question\[s\] 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:
True
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?: