NCT04370587 · ImmVira Pharma Co. Ltd
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
What this study is about
This is a Phase 1/2a, where both patients and doctors know the treatment given, study to evaluate the safety and preliminary effectiveness of intratumoral T3011 given alone and in combination with given through a vein (IV) pembrolizumab in partients with advanced or metastatic solid tumors.
View original scientific description
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.
Interventions
BIOLOGICAL
T3011
T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
COMBINATION_PRODUCT
T3011 + pembrolizumab
T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
Primary outcome measures
Safety and tolerability of escalating doses T3011
Time frame: Up to 2 years from first dose of T3011
Number of participants in dose escalating cohorts with dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
To determine the dose(s) of T3011 to be examined in Phase 2a
Time frame: Through the first two T3011 injections (approximately 28 days)
Incidence of DLTs
Safety and tolerability of T3011 dose(s) selected from Phase 1 in disease specific cohorts
Time frame: Up to 2 years from first dose of T3011
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Characterize the safety and tolerability of T3011 in combination with pembrolizumab
Time frame: Up to 2 years from first dose of T3011
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Characterize the safety and tolerability of T3011 in combination with pembrolizumab in participants who progress on T3011 alone
Time frame: Up to 2 years from first dose of T3011
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 18 years or older. 2. Disease progression after standard of care (SOC) therapy or in the opinion of 3. The Investigator unlikely to benefit from SOC therapy. Inclusion Diagnosis Phase 1 - Histologically or pathologically confirmed locally recurrent or metastatic advanced malignancy. Phase 2a Part 1 i. Arm A - locally recurrent or metastatic melanoma. Participants must have received no more than 3 prior regimens for advanced or metastatic disease. ii. Arm B - locally recurrent or metastatic HNSCC. It must also meet the following criteria: 1) Disease progression to platinum-containing chemotherapy; 2) Failure to anti-PD-1/PDL1 blockade after receiving at least 2 doses alone or in combination. iii. Arm C - Sarcoma. Participants must have received no more than three lines of prior anti-cancer therapies. iv. Arm D - locally recurrent or metastatic cSCC. Participants must have received no more than 3 prior regimens for advanced or metastatic di
Where
- Gilbert, Arizona
- Boston, Massachusetts
- Pittsburgh, Pennsylvania
- Dallas, Texas
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 8, 2025 · Source of record for eligibility and locations