Study on TER-2013 for Patients with Advanced Solid Tumors with Specific Genetic Changes
Sponsor: Terremoto Biosciences Inc.
ClinicalTrials ID:NCT07109726
This clinical trial is testing a new drug, TER-2013, to see if it is safe and effective for treating advanced solid tumors that have specific genetic changes in the AKT/PI3K/PTEN pathway.
Patient Parameters
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Program Overview
The study aims to evaluate the safety and effectiveness of a new treatment, TER-2013, for patients with advanced solid tumors that have specific genetic changes. The trial will be conducted in two parts: the first part will determine the best dose of TER-2013, and the second part will expand the study to more patients to further assess its effects.
Description
This is the first time TER-2013 is being tested in humans. The trial will look at how safe and tolerable the drug is, how it moves through the body, and its effects on tumors. The study will be conducted in two phases. In the first phase, researchers will gradually increase the dose of TER-2013 to find the highest dose that patients can tolerate. In the second phase, more patients will receive the drug to see how well it works against tumors. Some patients will receive TER-2013 alone, while others will receive it in combination with another drug called fulvestrant.
Eligibility Criteria
Exclusion Criteria
- Have other specific genetic mutations alongside the AKT/PI3K/PTEN changes.
- Have significant issues with blood sugar levels.
- Have active cancer spread to the brain or the lining of the brain.
- Have had significant coughing up of blood or bleeding within four weeks before starting the study.
- Have digestive issues that could affect how the body absorbs the study drug.
- Have previously received certain treatments, such as AKT inhibitors or other drugs targeting the AKT/PI3K/PTEN pathway, depending on the study group.
- Other specific criteria may apply.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Florida Cancer Specialists - Lake Nona | 32827 | Orlando | Florida |
| Massachusetts General Hospital | 02144 | Boston | Massachusetts |
| Nebraska Cancer Specialists | 68130 | Omaha | Nebraska |
| Carolina BioOncology Institute | 28078 | Huntersville | North Carolina |
| Sarah Cannon Nashville | 37203 | Nashville | Tennessee |
| NEXT Oncology | 78229 | Austin | Texas |
| START Center for Cancer Research | 78229 | San Antonio | Texas |
| START Center for Cancer Research | 84119 | West Valley City | Utah |
| NEXT Oncology | 22031 | Fairfax | Virginia |
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