Actively Recruiting
Phase 1 Trial of Intratumoral MQ710 Alone or With Pembrolizumab for Advanced Solid Tumors
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-08-12
56
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of MQ710 in people with advanced solid tumor cancers that have returned, spread, or worsened after standard treatments, or for whom no standard treatments are available. This phase 1 study aims to find the highest dose of MQ710 that causes few or mild side effects. The trial includes various types of solid tumors such as cutaneous squamous cell carcinoma, basal cell carcinoma, melanoma, and others. Participants will receive MQ710 injected directly into their tumors, either alone or combined with pembrolizumab, which is administered intravenously every three weeks at a standard dose. The study involves a dose escalation group using a 33 scheme to find the safe dose range, followed by a dose expansion group to further evaluate the chosen doses of MQ710 alone or with pembrolizumab. Treatment schedules and doses are carefully monitored throughout the trial. During the study, participants will undergo tumor biopsies, assessments of tumor response, and safety monitoring for up to two years after treatment. Researchers will review side effects, laboratory tests, and overall health status to evaluate the safety of MQ710. Participants must comply with study procedures, including regular visits, tumor evaluations, and use of contraception if applicable. The study duration may vary depending on individual response and study phase completion.
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 years or older
- Diagnosed with advanced or metastatic cancer that has relapsed, is refractory, or has no standard treatments available
- At least two tumors suitable for direct or ultrasound-guided injection, with one measurable lesion if in Part 2
- Willing to undergo mandatory initial screening biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No curative treatment options including surgery or definitive radiation, or such options carry significant morbidity
- Advanced disease progressed on standard therapy or lacking standard therapy options
- Predicted life expectancy of 3 months or more
- Ability to provide written informed consent
- Adequate renal, hepatic, bone marrow, and hematologic function as defined by study criteria
- Negative pregnancy test for females of child-bearing potential and agreement to use contraception
- Prior non-immunotherapy anti-tumor treatments discontinued more than 4 weeks before enrollment
- Patients who failed prior anti-PD1/-PDL1 therapies allowed with specific washout periods
- Ability to comply with study procedures
You will not qualify if you...
- Previous splenectomy
- Active infections requiring antibiotics or recurrent fevers above 38°C
- Active viral infections including hepatitis B, hepatitis C, or HIV with low CD4 count
- Incomplete recovery from surgery or healing of incision site
- Recent severe gastrointestinal bleeding or major thromboembolic events within 3 months
- History of serious cardiac events in past 6 months
- Uncontrolled infection within 6 months prior to study
- Significant bleeding requiring hospitalization in past 12 months
- Recent treatment with immune checkpoint inhibitors or immune-stimulatory agents
- Recent chemotherapy, radiotherapy, biological cancer therapy, targeted therapy, investigational drug, or major surgery within 28 days
- Known active CNS metastases or carcinomatous meningitis
- Recent live vaccine within 28 days
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Tumors contacting or penetrating major blood vessels or hollow organs posing perforation risk
- Risk of airway compromise due to tumor swelling
- History of autoimmune disease requiring systemic treatment in past 2 years
- History of chronic liver disease or hepatic cirrhosis
- History of pulmonary fibrosis, pneumonitis, or active interstitial lung disease requiring steroids
- Baseline oxygen saturation below 92% on room air
- History of re-irradiation involving carotid arteries
- History of leukemia with exceptions
- Current use of steroids ≥10 mg prednisone daily or immunosuppressants within 2 weeks of treatment
- Serious medical or psychological conditions increasing risk or impairing participation
- Known allergy to MQ710 products or formulation
- Requirement for anticoagulation therapy such as warfarin
Research Team
L
Lara Dunn, MD
A
Anthony Rossi, MD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here