Advanced Solid TumorPhase 1NCT06514651
MAQ-001 in Patients With Advanced Solid Tumors
A Phase 1 study testing MAQ-001 and Ipilimumab in people with Advanced Solid Tumor, run by MabQuest SA at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- MAQ-001 and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Jun 2024to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients aged ≥ 18 years.
- Patients who have advanced solid tumors or lymphomas for which an anti-PD-1/PDL-1 has been approved as single agent by the EMA (including but not limited to: melanoma, NSCLC, SCLC, HNSCC, classical HD, primary mediastinal LBCL, urothelial carcinoma, MSI-H cancer, gastric cancer, esophageal cancer, cervical cancer, HCC, merkel, renal cell carcinoma, endometrial cancer, TMB-H cancer, cutaneous SCC, TNBC, unresectable basal cell cancer) with no available approved therapeutic alternatives. In addition, patients with rare tumors for which significant activity of anti-PD1 has been observed (e.g., TLS+ sarcomas, alveolar soft part sarcomas, etc.) may enroll after discussion with the Sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically/cytologically confirmed diagnosis of a solid tumor malignancy
- Measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Life expectancy > 12 weeks
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- Patients who have received prior anti-PD-1, anti-PDL-1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable.
- Demonstrate adequate organ function
- Contraception
- For women: negative pregnancy test for women of child-bearing potential*; must be surgically sterile, postmenopausal, or compliant with an acceptable contraceptive regimen during and for 4 months after the treatment period. Abstinence is not considered an adequate contraceptive regimen.
- For men: must be surgically sterile, or compliant with a contraceptive regimen during and for a minimum of 4 months after the treatment period.
- Adequate knowledge in speaking and reading local language. * A woman is considered of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
Who cannot join
- Patients have a known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
- Patients have a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Patients have a known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is detected).
- Patients have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study drug.
- Patients have received prior anti-cancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter.
- Patients have not recovered adequately (≤ Grade 1) from AEs and/or complications from any major surgery prior to starting therapy.
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- Patients who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents.
- Patients have a history of organ transplant that requires use of immune suppressive agents.
- Patients have an active malignancy not related to the current diagnosed malignancy.
- Patients must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy, including but not limited to grade ≥2 myocarditis, grade ≥3 pneumonitis, or grade ≥3 toxicities not listed above.
- All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
- Patients taking steroids at a dose >10 mg prednisone equivalent daily, or any other immunosuppressive drugs within 28 days prior to the first dose of MAQ-001. However, patients are allowed to use topical or inhaled glucocorticoids and adrenal glucocorticoids replacement therapy at an effective dose equivalent to ≤ 10 mg/day of prednisone.
- Uncontrolled intercurrent illness, that would limit compliance with study requirements, substantially increase the risk of incurring AEs or compromise the ability of the subject to give written informed consent.
- Any condition that, in the opinion of the investigator, would interfere with the evaluation of the investigational product or interpretation of the patient's safety or study results, or not suitable for inclusion as judged by the investigator.
- Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Patients had cerebrovascular accident, myocardial infarction, unstable angina, poorly controlled arrhythmia occurring within 6 months of enrollment.
- Patients have cardiac insufficiency of Grade III or IV according to the New York Heart Association (NYHA) classification.
- Patients have interstitial pneumonitis, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, and/or severely impaired lung function, that may interfere with the detection and management of suspected MAQ-001-related pulmonary toxicity.
- Administration of live vaccines within 28 days prior to the first dose. Patients may receive inactivated viral vaccines for seasonal influenza and 2019-nCoV vaccines but may not receive live attenuated influenza vaccines via the intranasal route.
- Patients had a major surgery within 28 days prior to the first dose of investigational product. A major surgery is defined as a surgery that takes at least 3 weeks of postoperative recovery before receiving treatment in this study.
- Patients have known hypersensitivity or contraindication to anti-PDL1.
- For patients in Phase IB: known hypersensitivity or contraindication to ipilimumab.
- Pregnancy or lactation.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Centre Léon Bérard
Lyon
- Not yet recruiting
Institut Gustave Roussy
Paris
- Not yet recruiting
Centre Eugene Marquis
Rennes
- Recruiting
Oncopole Claudius Regaud Toulouse
Toulouse
About this study
Official title: 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
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.
Read more
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
- Being tested
- MAQ-001, Ipilimumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAQ-001Drug
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
IpilimumabDrug
Also called Yervoy
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 group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 1mg/kg of MAQ-001 administered intravenously every 3 weeks Receives: Drug: MAQ-001 |
| Cohort 2 | Experimental | 3 mg/kg of MAQ-001 administered intravenously every 3 weeks Receives: Drug: MAQ-001 |
| Cohort 3 | Experimental | 10 mg/kg of MAQ-001 administered intravenously every 3 weeks Receives: Drug: MAQ-001 |
| Regimen 1 | Experimental | 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) Receives: Drug: MAQ-001; Drug: Ipilimumab |
| Regimen 2 | Experimental | 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) Receives: Drug: MAQ-001; Drug: Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: First 21-day treatment cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start6 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MabQuest SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06514651
- Sponsor's protocol ID
- MQ01
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06514651
- Acronym / sponsor ID
- MQ01
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- MabQuest SAIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: MAQ-0011mg/kg of MAQ-001 administered intravenously every 3 weeks |
| Cohort 2 | Experimental | Drug: MAQ-0013 mg/kg of MAQ-001 administered intravenously every 3 weeks |
| Cohort 3 | Experimental | Drug: MAQ-00110 mg/kg of MAQ-001 administered intravenously every 3 weeks |
| Regimen 1 | Experimental | Drug: MAQ-001, Drug: IpilimumabMAQ-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) |
| Regimen 2 | Experimental | Drug: MAQ-001, Drug: IpilimumabMAQ-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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female patients aged ≥ 18 years.
- Patients who have advanced solid tumors or lymphomas for which an anti-PD-1/PDL-1 has been approved as single agent by the EMA (including but not limited to: melanoma, NSCLC, SCLC, HNSCC, classical HD, primary mediastinal LBCL, urothelial carcinoma, MSI-H cancer, gastric cancer, esophageal cancer, cervical cancer, HCC, merkel, renal cell carcinoma, endometrial cancer, TMB-H cancer, cutaneous SCC, TNBC, unresectable basal cell cancer) with no available approved therapeutic alternatives. In addition, patients with rare tumors for which significant activity of anti-PD1 has been observed (e.g., TLS+ sarcomas, alveolar soft part sarcomas, etc.) may enroll after discussion with the Sponsor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Histologically/cytologically confirmed diagnosis of a solid tumor malignancy
- Measurable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Key exclusion criteria (23 listed)
- Patients have a known uncontrolled central nervous system (CNS) metastases and/or carcinomatous meningitis or untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
- Patients have a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies).
- Patients have a known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus ribonucleic acid (HCV RNA) (qualitative) is detected).
- Patients have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study drug.
- Patients have received prior anti-cancer therapy (chemotherapy, targeted therapies, radiotherapy, or immunotherapy) within 21 days, or less than 5 times the half-life of the most recent therapy prior to study Day 1, whichever is shorter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAQ-001MAQ-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 | Cohort 1, Cohort 2, Cohort 3, Regimen 1, Regimen 2 |
| IpilimumabAlso: YervoyIpilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system | Drug | Regimen 1, Regimen 2 |
Primary outcome
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
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
Maximum Administered Dose (MAD) in monotherapy and in combination with ipilimumab at the end of Phase IA and IB, respectively
Time frame: up to 2 years
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
Incidence and severity of treatment-emergent adverse events (TEAEs) throughout the observation period
Time frame: First 21-day treatment cycle
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
Incidence and severity of treatment-emergent serious adverse events (TESAEs) throughout the observation period
Time frame: First 21-day treatment cycle
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
Incidence and severity of Dose Limiting Toxicity (DLT) during the first 21-day treatment cycle
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MAQ-001 and Ipilimumab in people with Advanced Solid Tumor, run by MabQuest SA at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Pantaleo, MD (+41792142262, mq01@mabquest.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.