Study on TILT-123 Virus with Pembrolizumab and Chemotherapy for Treating Ovarian Cancer
Sponsor: TILT Biotherapeutics Ltd.
ClinicalTrials ID:NCT05271318
This clinical trial is testing a new treatment using a virus called TILT-123, combined with the drug Pembrolizumab and chemotherapy, to see if it is safe and effective for women with ovarian cancer that hasn't responded to standard treatments.
Patient Parameters
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Program Overview
The study aims to evaluate the safety of a new treatment involving a virus called TILT-123, which is designed to attack cancer cells, in combination with Pembrolizumab, an immunotherapy drug, and a chemotherapy drug called Pegylated Liposomal Doxorubicin. This treatment is for women with ovarian cancer that has not responded to or has returned after platinum-based chemotherapy.
Description
This trial is exploring a new treatment for ovarian cancer that hasn't responded to standard platinum-based chemotherapy. The treatment involves using a virus called TILT-123, which is designed to attack cancer cells by producing substances that help the immune system fight cancer. This virus is used together with Pembrolizumab, a drug that helps the immune system recognize and attack cancer cells, and Pegylated Liposomal Doxorubicin, a form of chemotherapy. The study is being conducted in multiple centers across different countries and is divided into different phases to determine the best dose and evaluate the safety of the treatment.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Diagnosed with ovarian cancer that has not responded to or has returned after platinum-based chemotherapy.
- Have at least one tumor that can be injected with the virus.
- Have good organ function based on specific blood tests.
- Agree to use effective birth control during the study and for 120 days after treatment.
- Have a good overall health status with a performance score of 0-1.
- Life expectancy of more than 3 months.
- Able to understand and agree to the study requirements.
Exclusion Criteria
- Have an active autoimmune disease requiring treatment in the past 2 years.
- Have a diagnosis of immunodeficiency or are on high-dose steroids or other immunosuppressive drugs.
- Have received any cancer treatment within 30 days before the study starts.
- Have not recovered from side effects of previous treatments.
- Have had recent radiation therapy or certain other cancer treatments.
- Have uncontrolled heart or blood vessel diseases.
- Have a history of severe liver problems or certain infections like hepatitis or HIV.
- Are pregnant, breastfeeding, or planning to become pregnant.
- Have another active cancer or brain metastases that are not stable.
- Have an active infection or a history of lung inflammation requiring steroids.
- Have a psychiatric or substance abuse disorder that would interfere with the study.
- Are allergic to the study drugs or have had an organ transplant.
- Have received a live vaccine within 30 days before starting the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 55905 | Rochester | Minnesota |
| Northwell Heatlh/Lenox Hill Hospital | 10075 | New York City | New York |
| Gabrail Cancer and Research Center | 44718 | Canton | Ohio |
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