MAQ-001 in Patients With Advanced Solid Tumors
NCT Number: NCT06514651
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumor
Interventions: DRUG: MAQ-001|DRUG: Ipilimumab
Sponsor: MabQuest SA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-06
Completion Date: 2028-06-30
Locations: Centre Léon Bérard, Lyon, France|Institut Gustave Roussy, Paris, France|Centre Eugene Marquis, Rennes, France|Oncopole Claudius Regaud Toulouse, Toulouse, France

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

Primary Outcome Measures: Maximum Tolerated Dose (MTD) in monotherapy and in combination with ipilimumab at the end of Phase IA and IB, respectively, Number and percentage of subjects experiencing Treatment Emergent Adverse Event (TEAE), serious TEAE, TEAE related to investigational products and serious TEAE related to investigational products will be described as well as the number and percentage of events by dose level and overall, up to 2 years|Maximum Administered Dose (MAD) in monotherapy and in combination with ipilimumab at the end of Phase IA and IB, respectively, Number and percentage of subjects experiencing Treatment Emergent Adverse Event (TEAE), serious TEAE, TEAE related to investigational products and serious TEAE related to investigational products will be described as well as the number and percentage of events by dose level and overall, up to 2 years|Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the observation period, Number and percentage of subjects experiencing Treatment Emergent Adverse Event (TEAE), TEAE related to investigational products products will be described as well as the number and percentage of events by dose level and overall, First 21-day treatment cycle|Incidence and severity of treatment-emergent serious adverse events (TESAEs) throughout the observation period, Number and percentage of subjects experiencing serious Treatment Emergent Adverse Event (TEAE), serious TEAE related to investigational products will be described as well as the number and percentage of events by dose level and overall, First 21-day treatment cycle|Incidence and severity of Dose Limiting Toxicity (DLT) during the first 21-day treatment cycle, number and percentage at each dose level and number and percentage of patients who will have developed a DLT in the first 21 days in each dose level, First 21-day treatment cycle