RecruitingPhase 1Phase 2NCT06609005

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer


Sponsor

Shenzhen Ionova Life Sciences Co., Ltd.

Enrollment

84 participants

Start Date

Jan 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 and Phase 2 study to evaluate the safety and antitumor activity of INV-9956 in adult patients with advanced metastatic Castration Resistant Prostate Cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called INV-9956 for men with advanced prostate cancer that has stopped responding to hormone therapy (called castrate-resistant prostate cancer). Researchers want to learn whether the drug is safe, how the body processes it, and whether it has any anti-cancer effects. **You may be eligible if...** - You are a male aged 18 or older - You have prostate cancer that has spread to other parts of the body - Your cancer is no longer responding to hormone-reducing treatments (testosterone levels below 50 ng/dL) - You have already received at least one hormone-targeted therapy (such as abiraterone or enzalutamide) - You are in reasonably good health with adequate organ function - You have a life expectancy of more than 3 months **You may NOT be eligible if...** - You have significant uncontrolled medical conditions - You cannot swallow oral medications - Your blood clotting, liver, or kidney function falls outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGINV-9956

INV-9956 is co-administered with dexamethasone and fludrocortisone acetate


Locations(17)

Honor Health

Scottsdale, Arizona, United States

Hoag Family Cancer Institute

Newport Beach, California, United States

UC Irvine Medical Center

Orange, California, United States

Next Oncology - Houston

Houston, Texas, United States

UT Health

San Antonio, Texas, United States

NEXT Oncology

Fairfax, Virginia, United States

Summit Cancer Centers

Spokane, Washington, United States

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

He'nan Cancer Hospital

Zhengzhou, He'Nan, China

Hu'nan Cancer Hospital

Changsha, Hu'Nan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Shandong Cancer Hospital

Ji'nan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT06609005


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