NCT06514651

MAQ-001 in Patients With Advanced Solid Tumors

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: MabQuest SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	MAQ-001	MAQ-001 is an anti-PD-1 monoclonal antibody that inhibits T cell exhaustion through an alternative mechanism, independent of PD-1/PDL-1 blockade
DRUG	Ipilimumab	Ipilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-06-30
• Completion: 2028-06-30
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

4 sites across 1 country: France