Study on Lamivudine for Treating Relapsed or Resistant Solid Tumors
Sponsor: Thomas Marron
ClinicalTrials ID:NCT06494579
This clinical trial is testing the safety and effectiveness of adding the drug Lamivudine to existing treatments for patients with solid tumors that have not responded to previous therapies. The study is being conducted at Mount Sinai Health System and aims to enroll 6-24 participants over two years.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if Lamivudine, when combined with ongoing PD-(L)1 blocking treatments, is safe and can help control solid tumors that have returned or not responded to previous treatments. The study will be conducted in two phases: Phase 1b will focus on safety and tolerability, while Phase 2 will assess the effectiveness of Lamivudine in improving treatment outcomes. Researchers will also look at how long patients live without the disease getting worse, overall survival rates, and how long the treatment effects last.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of a solid tumor.
- The cancer must have worsened after previous treatment with PD-1 or PD-L1 antibodies.
- Have tried all standard treatments or decided not to pursue them.
- Have had no more than one additional treatment since the last PD-(L)1 therapy.
- Be willing to provide blood samples at specific times during the study.
- Be 18 years or older.
- Have a performance status score of 0 to 2, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Women of childbearing potential and men must agree to use effective contraception during the study and for three months after.
- Be able to understand and sign a consent form.
- Have adequate organ and bone marrow function.
Exclusion Criteria
- Have received chemotherapy within 14 days before starting the study.
- Have received radiotherapy within 7 days before starting the study, except for palliative care.
- Be taking other experimental drugs.
- Have uncontrolled illnesses, such as infections requiring antibiotics, heart failure, or unstable angina.
- Be pregnant or breastfeeding.
- Have an immune deficiency or be on immunosuppressive therapy within 7 days before the study.
- Have active autoimmune diseases requiring treatment in the past year.
- Have conditions or treatments that could interfere with the study results.
- Be HIV positive with a detectable viral load or not on stable treatment.
- Have active Hepatitis B or C.
- Have had a bone marrow or organ transplant.
- Have received a live vaccine within 30 days before the study.
- Have allergies to protein-based treatments.
- Have a history of severe immune-related side effects from previous treatments.
- Have lung diseases like interstitial lung disease or pneumonitis from previous cancer treatments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | 10029 | New York | New York |
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