Actively Recruiting
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Led by ImmVira Pharma Co. Ltd · Updated on 2025-10-08
30
Participants Needed
9
Research Sites
329 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2a, open-label, study to evaluate the safety and preliminary efficacy of intratumoral T3011 given alone and in combination with intravenous pembrolizumab in partients with advanced or metastatic solid tumors.
CONDITIONS
Official Title
A Clinical Study of Intratumoral MVR-T3011 (T3011) Given as a Single Agent and in Combination With Intravenous Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Disease progression after standard of care therapy or unlikely to benefit from it
- Histologically or pathologically confirmed advanced or metastatic malignancy for Phase 1
- Arm A: Locally recurrent or metastatic melanoma with no more than 3 prior advanced treatments
- Arm B: Locally recurrent or metastatic head and neck squamous cell carcinoma with progression after platinum chemotherapy and anti-PD-1/PD-L1 blockade
- Arm C: Sarcoma with no more than three lines of prior anti-cancer therapies
- Arm D: Locally recurrent or metastatic cutaneous squamous cell carcinoma with no more than 3 prior advanced treatments
- Arm E: Advanced or recurrent non-small cell lung cancer without EGFR mutation or ALK rearrangement, with 1 to 3 prior anti-cancer therapies
- Measurable disease per RECIST version 1.1
- At least 1 tumor lesion accessible for intratumoral injection
- ECOG performance status 0-1
- Life expectancy greater than 12 weeks
- Adequate organ function based on laboratory tests
- Women of child-bearing potential and men must use contraception during and 6 months after treatment
- Negative pregnancy test for women of child-bearing potential before first dose
- At least 21 days since last anticancer therapy, radiotherapy, or surgery
- Recovered from prior anticancer therapy toxicities
- Willing to provide fresh tumor biopsy specimens
- Able to understand and comply with study requirements
- Signed informed consent form before screening procedures
You will not qualify if you...
- Only uninjectable tumors
- Tumors impinging on major airways or blood vessels
- For head and neck squamous cell carcinoma, prior re-irradiation including carotid artery
- More than 3 distant metastatic lymph node regions or lesions larger than 3 cm (non-sarcoma) or 5 cm (sarcoma) unless lesion is injectable
- Prior treatment with other oncolytic viruses, tumor vaccines, cellular therapy, or gene therapy
- Prior intolerance to anti-PD-(L)1 antibodies or history of immunotherapy-related pneumonitis
- Prior treatment with anti-PD-(L)1 antibodies combined with IL-12
- Need for ongoing therapy with drugs active against HSV
- Live or attenuated vaccines within 4 weeks before treatment
- Primary or acquired immunodeficiency
- Pregnant or breastfeeding
- Prior organ transplantation
- Active hepatitis B, hepatitis C, or HIV infection
- Active autoimmune disease or need for chronic steroids or immunosuppressives within 4 weeks before treatment
- History or presence of central nervous system metastases
- Seizure disorders within 6 months before screening
- Active oral or skin herpes lesions at screening
- Active interstitial lung disease or pneumonitis requiring steroids
- Significant heart disease or unstable angina
- Allergic reactions to HSV-1, IL-12, or anti-PD-1 antibody components
- Active COVID-19 infection
- Moderate to large pleural, pericardial, or abdominal effusions needing intervention
- Other conditions that may interfere with study conduct or interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 9 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Completed
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
4
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
5
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
6
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Southern Oncology
Bedford Park, Australia
Actively Recruiting
8
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Australia
Actively Recruiting
9
The Alfred
Melbourne, Australia
Actively Recruiting
Research Team
I
ImmVira Pharma Co. Ltd.
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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