Actively Recruiting
A First-In-Human Phase I Study of Intratumoral MQ710 Alone and With Pembrolizumab in Solid Tumors Safety and Tolerability of Escalating Multiple Doses of MQ710 in Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-03
56
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with solid tumor cancers that have returned, spread, or worsened after standard treatments, or when no standard treatments are available. This study aims to find the highest dose of MQ710, a modified virus therapy, that causes few or mild side effects in these patients. The trial is an open-label, phase 1 study focusing on safety and tolerability of this treatment in solid tumors. Participants will receive MQ710 injected directly into their tumors. Some will receive MQ710 alone, while others will receive MQ710 combined with pembrolizumab, a drug given intravenously every three weeks. The study includes a dose escalation phase to find the best dose, followed by groups receiving the established doses of MQ710 alone or with pembrolizumab. During the study, participants will have regular assessments including biopsies, physical exams, and monitoring for side effects. The study will review adverse events for up to two years to evaluate safety. Participants must comply with study procedures and will be closely monitored throughout the trial period, which started in May 2023 and is expected to continue until May 2028.
CONDITIONS
Brief Title
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or over
- Diagnosed advanced or metastatic cancer that has relapsed, is refractory to standard treatment, or has no standard treatment available
- At least 2 tumors suitable for direct or ultrasound-guided injection, including one measurable lesion if applicable
- Willing and able to undergo mandatory initial tumor biopsy
- ECOG performance status of 0 or 1
- No curative treatment options including surgery or radiation, or these options have significant morbidity
- Patients with advanced disease progressed on standard therapy or with contraindications to standard therapy
- Predicted life expectancy of 3 months or more
- Ability to comply with study procedures
- Adequate kidney, liver, and bone marrow function
- Negative pregnancy test for females of child-bearing potential and agreement to use contraception
- Prior non-immunotherapy cancer treatments stopped at least 4 weeks before enrollment
- Patients who failed prior anti-PD1/PDL1 therapy may be included with specific washout periods
- Specific cancer types allowed as detailed by study parts
You will not qualify if you...
- History of splenectomy
- Active infections requiring antibiotics or monitoring
- Positive for hepatitis B, C, or HIV with low CD4 count or recent antiviral treatment
- Incomplete healing from surgery
- Recent serious gastrointestinal bleeding or uncontrolled cardiac events
- Uncontrolled infection within 6 months
- Significant bleeding requiring hospitalization within 12 months
- Recent use of immune checkpoint inhibitors or immune-stimulatory treatments
- Recent chemotherapy, radiotherapy, or major surgery without recovery
- Known active central nervous system metastases
- Recent live vaccine
- Pregnancy, breastfeeding, or expecting to conceive/father children during trial
- Tumors contacting or penetrating major blood vessels or hollow organs
- Risk of airway compromise from tumor swelling
- History of autoimmune disease requiring systemic treatment
- Chronic liver disease or hepatic cirrhosis
- Interstitial lung disease or pulmonary fibrosis requiring treatment
- Low baseline oxygen levels
- History of certain leukemias or recent steroid/immunosuppressant use
- Serious medical or psychological conditions affecting study participation
- Known allergy to MQ710 components
- Need for anticoagulation therapy such as warfarin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until discontinuation
Participants receive multidose monotherapy with MQ710 injected directly into the tumor, or combination therapy with MQ710 plus pembrolizumab administered intravenously every 3 weeks.
Repeated visits every 3 weeks for dosing
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Active, Not Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Active, Not Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
L
Lara Dunn, MD
A
Anthony Rossi, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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