Trial Title:
MAQ-001 in Patients With Advanced Solid Tumors
NCT ID:
NCT06514651
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Ipilimumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
MAQ-001
Description:
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
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Regimen 1
Arm group label:
Regimen 2
Intervention type:
Drug
Intervention name:
Ipilimumab
Description:
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
Arm group label:
Regimen 1
Arm group label:
Regimen 2
Other name:
Yervoy
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients aged ≥ 18 years.
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
4. Histologically/cytologically confirmed diagnosis of a solid tumor malignancy
5. Measurable metastatic disease by Response Evaluation Criteria in Solid Tumors
(RECIST) 1.1
6. Life expectancy > 12 weeks
7. 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.
8. Demonstrate adequate organ function
9. 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.
10. 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.
Exclusion Criteria:
1. Patients have a known uncontrolled central nervous system (CNS) metastases and/or
carcinomatous meningitis or untreated CNS metastatic disease, leptomeningeal
disease, or cord compression.
2. Patients have a known history of human immunodeficiency virus (HIV) (HIV 1/2
antibodies).
3. 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).
4. 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.
5. 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.
6. Patients have not recovered adequately (≤ Grade 1) from AEs and/or complications
from any major surgery prior to starting therapy.
7. 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.
8. Patients have a history of organ transplant that requires use of immune suppressive
agents.
9. Patients have an active malignancy not related to the current diagnosed malignancy.
10. 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.
11. All AEs while receiving prior immunotherapy must have completely resolved or
resolved to Grade 1 prior to screening for this study.
12. 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.
13. 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.
14. 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.
15. 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.
16. Patients had cerebrovascular accident, myocardial infarction, unstable angina,
poorly controlled arrhythmia occurring within 6 months of enrollment.
17. Patients have cardiac insufficiency of Grade III or IV according to the New York
Heart Association (NYHA) classification.
18. 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.
19. 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.
20. 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.
21. Patients have known hypersensitivity or contraindication to anti-PDL1.
22. For patients in Phase IB: known hypersensitivity or contraindication to ipilimumab.
23. Pregnancy or lactation.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Léon Bérard
Address:
City:
Lyon
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Institut Gustave Roussy
Address:
City:
Paris
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Centre Eugene Marquis
Address:
City:
Rennes
Country:
France
Status:
Not yet recruiting
Facility:
Name:
Oncopole Claudius Regaud Toulouse
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Start date:
June 6, 2024
Completion date:
June 30, 2028
Lead sponsor:
Agency:
MabQuest SA
Agency class:
Industry
Source:
MabQuest SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06514651
