Study on New Treatment for Patients with Advanced Solid Tumors
Sponsor: Callio Therapeutics
ClinicalTrials ID:NCT07300943
This clinical trial is exploring a new treatment for adults with advanced solid tumors. The study will be conducted in two phases to determine the best dose and evaluate the treatment's effectiveness.
Patient Parameters
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Program Overview
The study aims to find the best dose and evaluate the effectiveness of a new treatment, CLIO-8221, for patients with advanced solid tumors. It will be conducted in two phases. Phase 1 will focus on finding the safest and most effective dose, while Phase 2 will test this dose in specific types of tumors to see how well it works.
Description
This clinical trial is divided into two main parts:
Phase 1: This phase will test different doses of the new treatment, CLIO-8221, to find the safest and most effective dose. A group of experts will review the safety data to help decide on the best dose. Additional patients may be enrolled to gather more information about the treatment's safety and how it works in the body.
Phase 2: In this phase, the treatment will be tested in specific types of tumors to see how well it works. The goal is to optimize the dose and gather preliminary information on its effectiveness. The data collected will help determine the recommended dose for future studies.
Eligibility Criteria
Inclusion Criteria
- Have advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body.
- Have already tried other treatments that were beneficial, unless they were not eligible, unwilling, or unable to access them.
- Have a heart function of 50% or higher as measured by specific heart tests.
- Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have measurable disease according to standard criteria at the start of the study.
Exclusion Criteria
- Have previously received a specific type of anti-tumor treatment known as ATRi.
- Have another type of cancer that could interfere with the study, except for certain low-risk cancers like treated skin cancer or localized prostate cancer.
- Have a history of uncontrolled seizures or significant neurological disorders, except for stable mild peripheral neuropathy.
- Have a significant autoimmune disease requiring high-dose immunosuppressive therapy.
- Have a severe infection that is not controlled within two weeks before starting the study.
- Have a history of liver disease or hepatitis in the past year.
- Have uncontrolled diabetes with high blood sugar levels.
- Have any other medical or personal issues that could affect safety or compliance with the study, as determined by the investigator.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| DFCI | 02215-5450 | Boston | Massachusetts |
| Sarah Cannon Research Institute 335 24th Avenue North, Suite 400 | 37203 | Nashville | Tennessee |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
| START San Antonio | 78229 | San Antonio | Texas |
| START Mountain | 84119 | West Valley City | Utah |
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