Study on the Safety and Effects of INV-9956 for Advanced Metastatic Castration Resistant Prostate Cancer
Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.
ClinicalTrials ID:NCT06609005
This clinical trial is testing a new drug, INV-9956, to see if it is safe and effective in treating advanced prostate cancer that has spread and is resistant to standard hormone therapy.
Patient Parameters
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Program Overview
The study is divided into two parts: Phase 1, which focuses on finding a safe dose of the new drug INV-9956, and Phase 2, which looks at how well the drug works in treating advanced prostate cancer that has spread and is resistant to hormone therapy. Participants will take the drug along with two other medications, dexamethasone and fludrocortisone, to help manage side effects. Each treatment cycle lasts 28 days, and the study includes a screening period of up to 28 days before starting treatment.
Description
This clinical trial is designed to evaluate the safety and effectiveness of a new drug called INV-9956 for treating advanced prostate cancer that has spread and is resistant to hormone therapy. The study is conducted in two phases: Phase 1 aims to determine the safest dose of the drug, while Phase 2 assesses its effectiveness in shrinking tumors or slowing their growth.
Participants will receive INV-9956 along with two other medications, dexamethasone and fludrocortisone, to help manage potential side effects. The study involves a screening period of up to 28 days to ensure participants meet all the criteria, followed by treatment cycles that last 28 days each. Researchers will monitor participants closely to evaluate the drug's safety and its impact on the cancer.
Eligibility Criteria
Inclusion Criteria
- Men aged 18 years or older.
- Diagnosed with prostate cancer that has spread and is resistant to hormone therapy.
- Currently receiving hormone therapy or have had surgery to remove the testicles.
- Previously treated with at least one type of chemotherapy and one hormone therapy.
- Good overall health with a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Adequate blood, liver, and kidney function.
- Able to swallow pills.
- Life expectancy of more than 3 months.
Exclusion Criteria
- Medical conditions affecting the digestive system that could interfere with drug absorption.
- History of problems with the pituitary or adrenal glands.
- Poorly controlled diabetes.
- Abnormal levels of potassium or sodium in the blood.
- Serious non-cancerous diseases that could affect the study.
- Unstable heart or blood vessel conditions, including recent heart attack or heart failure.
- Prolonged QT interval on an ECG.
- Active infections or conditions that make steroid use unsafe.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Honor Health | 85258 | Scottsdale | Arizona |
| Hoag Family Cancer Institute | 92663 | Newport Beach | California |
| UC Irvine Medical Center | 92868 | Orange | California |
| Next Oncology - Houston | 77054 | Houston | Texas |
| UT Health | 78229 | San Antonio | Texas |
| NEXT Oncology | 22031 | Fairfax | Virginia |
| Summit Cancer Centers | 99208 | Spokane | Washington |
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