Clinical Study of T3011 for Advanced or Metastatic Solid Tumors
This study is testing a new treatment called T3011, given directly into tumors (intratumoral injection), either alone or combined with pembrolizumab (an immunotherapy drug). It's for people aged 18 or older with advanced or metastatic solid tumors (cancers that have spread) that have progressed after standard treatments, or for whom standard treatments aren't suitable. The main goals are to find a safe dose of T3011 and to see how well it works. The study is currently unclear about its recruitment status. This trial is looking at different types of solid tumors, including melanoma, head and neck squamous cell carcinoma (HNSCC), sarcoma, and cutaneous squamous cell carcinoma (cSCC).
- Study design
- This is a Phase 1/2a, open-label study, meaning you and your doctors will know which treatment you are receiving. It will involve approximately 15 to 30 participants in the first phase, with more participants in later phases depending on the cancer type.
- What's involved
- T3011 will be given as an injection into the tumor every two weeks when given alone, or every three weeks when combined with intravenous (into a vein) pembrolizumab.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and tolerability will be monitored for up to two years from your first dose of T3011.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
Where it's being run
9 sites across 6 statesWho to contact
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What this trial measures
- Safety and tolerability of escalating doses T3011Up 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 2aThrough 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 cohortsUp 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 pembrolizumabUp 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 aloneUp to 2 years from first dose of T3011
Number of participants with treatment-emergent adverse events (TEAEs), and/or changes in clinical laboratory abnormalities.