Actively Recruiting
MAQ-001 in Patients With Advanced Solid Tumors
Led by MabQuest SA · Updated on 2024-07-23
30
Participants Needed
4
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
MAQ-001 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Diagnosed with advanced solid tumors or lymphomas approved for anti-PD-1/PDL-1 treatment with no available approved alternatives
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically or cytologically confirmed solid tumor malignancy
- Measurable metastatic disease by RECIST 1.1 criteria
- Life expectancy greater than 12 weeks
- Prior anti-PD-1, anti-PDL-1, or anti-CTLA-4 therapy allowed after appropriate washout
- Adequate organ function
- Women must have a negative pregnancy test if of childbearing potential and use contraception or be postmenopausal or surgically sterile
- Men must be surgically sterile or use contraception during and for 4 months after treatment
- Adequate knowledge of local language for communication
You will not qualify if you...
- Uncontrolled central nervous system metastases or untreated CNS metastatic disease
- Known HIV infection
- Active hepatitis B or hepatitis C infection
- Participation in another investigational study within 4 weeks before starting this study
- Recent anti-cancer therapy within 21 days or less than 5 times the half-life of prior therapy
- Incomplete recovery from major surgery or adverse events
- Active autoimmune disease requiring systemic treatment within past 3 months or severe history
- History of organ transplant requiring immunosuppression
- Active malignancy unrelated to current cancer
- Prior immunotherapy toxicity leading to permanent discontinuation
- Ongoing adverse events from prior immunotherapy not resolved to Grade 1
- Use of systemic steroids above 10 mg prednisone equivalent or immunosuppressants within 28 days prior to treatment
- Uncontrolled illnesses limiting study compliance or increasing risk
- Investigator judgment deeming patient unsuitable
- Recent serious cardiovascular events within 6 months
- Cardiac insufficiency Grade III or IV by NYHA classification
- Lung diseases that may interfere with drug toxicity detection
- Live vaccine administration within 28 days before treatment
- Major surgery within 28 days before treatment
- Known hypersensitivity to anti-PDL1 or ipilimumab (Phase IB only)
- Pregnancy or lactation
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Centre Léon Bérard
Lyon, France
Not Yet Recruiting
2
Institut Gustave Roussy
Paris, France
Not Yet Recruiting
3
Centre Eugene Marquis
Rennes, France
Not Yet Recruiting
4
Oncopole Claudius Regaud Toulouse
Toulouse, France
Actively Recruiting
Research Team
G
Giuseppe Pantaleo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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