Study on 9-ING-41 for Patients with Advanced Cancers
Sponsor: Actuate Therapeutics Inc.
ClinicalTrials ID:NCT03678883
This clinical trial is testing a new drug called 9-ING-41 to see if it is safe and effective for treating advanced cancers that have not responded to other treatments. The study will look at how well the drug works on its own and when combined with other cancer treatments.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and effectiveness of a new drug, 9-ING-41, in patients with advanced cancers that have not responded to standard treatments. 9-ING-41 is designed to target a specific protein involved in cancer growth, potentially helping to shrink tumors and overcome resistance to other therapies. The study will test the drug both by itself and in combination with other cancer-fighting drugs.
Description
9-ING-41 is a new type of drug that targets a protein called GSK-3β, which plays a role in the growth and survival of cancer cells. By inhibiting this protein, 9-ING-41 may help stop cancer cells from growing and make them more sensitive to other treatments. This study will test 9-ING-41 in patients with various types of advanced cancers, including those that have not responded to other treatments or have returned after treatment.
The study is divided into three parts:
- Part 1: Tested 9-ING-41 alone to find the best dose.
- Part 2: Tested 9-ING-41 with other cancer drugs to find the best combination doses.
- Part 3: Currently testing 9-ING-41 with two other drugs, gemcitabine and nab-paclitaxel, in patients with advanced pancreatic cancer to see if this combination works better than the two drugs alone.
Participants will receive the study drug and undergo regular health checks to monitor their response and any side effects.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have advanced or metastatic cancer that has not responded to other treatments or has returned after treatment.
- Have at least one tumor that can be measured by scans.
- Have good overall health and organ function based on specific medical tests.
- Women must not be pregnant or breastfeeding and must agree to use birth control during the study.
- Men must agree to use birth control to prevent pregnancy in partners during the study.
- Must not be taking any other experimental drugs.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Allergic to any components of 9-ING-41.
- Have not recovered from side effects of previous cancer treatments.
- Have significant heart problems or recent heart attack.
- Have rapidly progressing brain cancer that is causing symptoms.
- Have had major surgery recently or plan to have major surgery during the study.
- Have another active cancer besides the one being studied.
- Are part of a vulnerable population, such as prisoners.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic | 85054 | Phoenix | Arizona |
| Arizona Oncology Associates | 85704 | Tucson | Arizona |
| The University of Arizona Cancer Center | 85719 | Tucson | Arizona |
| University of California Irvine Health | 92868 | Orange | California |
| UCSF Helen Diller Family Comprehensive Cancer Center | 94115 | San Francisco | California |
| Christiana Care Health Services | 19709 | Newark | Delaware |
| Sibley Memorial Hospital | 20016 | Washington D.C. | District of Columbia |
| Florida Cancer Specialists - South | 33901 | Fort Myers | Florida |
| Miami Cancer Institute | 33176 | Miami | Florida |
| Florida Cancer Specialists - North | 33705 | St. Petersburg | Florida |
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