MAQ-001 in Patients With Advanced Solid Tumors

Sponsor
MabQuest SA
Study ID
NCT06514651
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MAQ-001 — DRUG
    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 — DRUG
    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

Study Details

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

Key Dates

Start date
Jun 6, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    1mg/kg of MAQ-001 administered intravenously every 3 weeks
  • Experimental: Cohort 2
    3 mg/kg of MAQ-001 administered intravenously every 3 weeks
  • Experimental: Cohort 3
    10 mg/kg of MAQ-001 administered intravenously every 3 weeks
  • Experimental: Regimen 1
    MAQ-001 at 1 mg/kg in combination with ipilimumab at 3 mg/kg administered intravenously every 3 weeks for the first 4 doses, followed by the maintenance phase of MAQ-001 monotherapy administered intravenously at a dose of 3 mg/kg every 3 weeks (q3W)
  • Experimental: Regimen 2
    MAQ-001 at 3 mg/kg in combination with ipilimumab at 1 mg/kg administered intravenously every 3 weeks for the first 4 doses, followed by the maintenance phase of MAQ-001 monotherapy administered intravenously at a dose of 3 mg/kg every 3 weeks (q3W)

Primary Outcome Measure

Maximum Tolerated Dose (MTD) in monotherapy and in combination with ipilimumab at the end of Phase IA and IB, respectively [ Time Frame: up to 2 years ]

Central Contacts

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