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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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
Centre Léon Bérard
Lyon, France
NOT_YET_RECRUITINGInstitut Gustave Roussy
Paris, France
NOT_YET_RECRUITINGCentre Eugene Marquis
Rennes, France
NOT_YET_RECRUITINGOncopole Claudius Regaud Toulouse
Toulouse, France
RECRUITINGMaximum 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: First 21-day treatment cycle
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.