Study on Intravenous T3011 Alone and with Other Treatments for Advanced Solid Tumors
Sponsor: ImmVira Pharma Co. Ltd
ClinicalTrials ID:NCT04780217
This clinical trial is testing a new drug, T3011, given through an IV, both by itself and with other treatments, to see if it is safe and effective for adults with advanced solid tumors that have returned or spread after standard treatments.
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Program Overview
This study is exploring the safety and effectiveness of a new drug called T3011, administered through an IV, for adults with advanced solid tumors that have come back or spread after standard treatments. The study is divided into two phases: Phase 1 will test different doses of T3011 to find the safest dose, while Phase 2a will expand on these results to further evaluate the drug's effects.
Description
The study is conducted in two parts:
Phase 1: T3011 will be given through an IV to patients with advanced solid tumors that have returned or spread after standard treatments. Different doses will be tested to find the safest one. Groups of three patients will receive each dose, and more patients may be added if needed to assess safety. Around 36-42 patients will participate in this phase.
Phase 2a: Based on the results from Phase 1, this phase will expand to further evaluate the effects of T3011.
Participants must have a confirmed diagnosis of certain types of advanced solid tumors, be 18 years or older, and meet specific health criteria. They must also agree to use effective birth control during the study and for six months after the last dose. Women must have a negative pregnancy test before starting the treatment.
The study excludes individuals who have had certain previous treatments, have rapidly progressing disease, or have specific health conditions that could interfere with the study. Participants will need to provide tumor samples and agree to follow the study procedures.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced solid tumors, such as lung, liver, colorectal, ovarian, or endometrial cancer.
- The cancer must have progressed after standard treatments or be unlikely to respond to them.
- Be 18 years or older.
- Have at least one measurable tumor.
- Be in good overall health with a performance status of 0 or 1.
- Have a life expectancy of at least 12 weeks.
- Have adequate blood cell counts and organ function.
- Women must use effective birth control and have a negative pregnancy test before starting treatment.
- Must have completed any previous cancer treatments at least 21 days before starting the study.
- Be willing to provide tumor samples and follow study procedures.
Exclusion Criteria
- Have had certain previous treatments like other oncolytic viruses or specific immunotherapies.
- Have rapidly progressing disease that cannot tolerate a break from treatment.
- Have a history of intolerance to certain immunotherapies.
- Require ongoing treatment with drugs active against herpes simplex virus (HSV).
- Have received live vaccines within four weeks before starting the study.
- Have certain immune system disorders or active infections.
- Be pregnant or breastfeeding.
- Have had a splenectomy or organ transplant.
- Have active hepatitis B or C infections.
- Have active autoimmune diseases requiring high-dose steroids.
- Have untreated or symptomatic brain metastases.
- Have a history of other cancers unless treated and in remission for three years.
- Have significant fluid buildup in the body requiring intervention.
- Have unexplained fever or seizure disorders.
- Have active herpes lesions.
- Plan to receive other anti-cancer treatments during the study.
- Have significant heart disease or psychiatric disorders.
- Have a history of substance abuse within six months before the study.
- Have other conditions that may interfere with the study.
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