Study on the Safety and Early Effects of SA53-OS in Patients with Advanced or Metastatic Solid Tumors
Sponsor: Lamassu Bio Inc
ClinicalTrials ID:NCT06578624
This clinical trial is testing a new drug, SA53-OS, to see if it is safe and effective for adults with advanced solid tumors that have not responded to other treatments. The study will also determine the best dose to use in future research.
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Program Overview
The study aims to evaluate the safety, effectiveness, and how the body processes SA53-OS in adults with advanced solid tumors that have not responded to other treatments. The study has two parts: Part 1, where different doses of SA53-OS are tested to find the highest dose that can be given safely, and Part 2a, where the best dose is given to patients with specific types of cancer to see how well it works. SA53-OS is taken as a liquid by mouth for three days every three weeks, for up to two years.
Description
This study is in two phases: Phase 1 and Phase 2a.
In Phase 1, the focus is on finding the safest dose of SA53-OS, a new drug that helps the body's natural tumor-fighting protein, p53, work better. Patients with advanced solid tumors that have not responded to other treatments will receive increasing doses of SA53-OS to find the maximum dose that does not cause severe side effects. This phase will help determine the best dose to use in future studies.
In Phase 2a, the study will test the effectiveness of SA53-OS at the best dose found in Phase 1. This phase will include patients with a specific type of cancer called dedifferentiated liposarcoma (DD LPS) and other solid tumors. The goal is to see if SA53-OS can help shrink tumors or stop them from growing. Patients will continue treatment until their cancer progresses, they experience severe side effects, or they complete two years of treatment. If a complete response is achieved, treatment may continue for at least six months.
Participants will take SA53-OS as a liquid by mouth for three consecutive days every three weeks. The study will monitor the safety and effectiveness of the treatment, as well as how the body processes the drug.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of advanced or metastatic solid tumor or non-Hodgkin lymphoma, with no standard treatment options available or if standard treatment was declined.
- Tumor must have a specific genetic feature called p53 wild-type.
- For Phase 2a, patients must have either dedifferentiated liposarcoma (DD LPS) with a specific genetic change or other solid tumors with p53 wild-type.
- Must be 18 years or older.
- Must have recovered from any side effects of previous cancer treatments to a mild level.
- Must be in good overall health, with a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Must agree to use effective birth control during the study and for at least three months after stopping treatment.
Exclusion Criteria
- Need for major surgery or radiation therapy in the next six weeks.
- Have untreated or active cancer spread to the brain.
- Have HIV or active hepatitis B or C infections.
- Have had a blood clot requiring treatment in the last six months.
- Have had a heart attack in the last six months.
- Have serious heart conditions, such as unstable chest pain or uncontrolled high blood pressure.
- Have a history of heart rhythm problems that increase the risk of a condition called Torsades de Pointes.
- Have a known bleeding disorder or conditions that increase the risk of major bleeding.
- Are taking blood thinners or medications that affect blood clotting.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Gabrail Cancer Center | 44718 | Canton | Ohio |
| Cleveland Clinic Taussig Cancer Institute | 44195 | Cleveland | Ohio |
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