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

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Metastatic Castration Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06609005

Run by

Shenzhen Ionova Life Sciences Co., Ltd.

People needed

84

Starts

2025-01-23

Expected to finish

2028-01-17

Last updated by the study team

2026-06-04

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained.
• Male aged ≥ 18 years.
• Histologically confirmed adenocarcinoma of the prostate.
• Castration resistant prostate cancer with serum testosterone <50 ng/dL.
• Metastatic disease.
• Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
• Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled.
• ECOG performance status 0-1.
• Adequate marrow, liver and kidney function.
• INR ≤1.5.
• Able to swallow study treatment.
• Has a life expectancy of > 3 months.

You may not qualify if…

• Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption.
• History of pituitary or adrenal dysfunction.
• Poorly controlled diabetes mellitus.
• Clinically significant abnormality in serum potassium and sodium.
• Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor.
• Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
• History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
• Prolonged QTcF interval.
• Active infection or other medical condition that would make corticosteroid contraindicated.

Where it is running

• Shandong Cancer Hospital — Ji'nan, Shandong, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• NEXT Oncology — Fairfax, Virginia, United States (enrolling)
• The First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (enrolling)
• Summit Cancer Centers — Spokane, Washington, United States (enrolling)
• Honor Health — Scottsdale, Arizona, United States (enrolling)
• Hoag Family Cancer Institute — Newport Beach, California, United States (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• UC Irvine Medical Center — Orange, California, United States (enrolling)
• He'nan Cancer Hospital — Zhengzhou, He'Nan, China (enrolling)
• Next Oncology - Houston — Houston, Texas, United States (enrolling)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (enrolling)
• UT Health — San Antonio, Texas, United States (enrolling)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
• Beijing GoBroad Hospital — Beijing, Beijing Municipality, China
• The First People's Hospital of Foshan — Foshan, Guangdong, China
• Hu'nan Cancer Hospital — Changsha, Hu'Nan, China
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Hubei, Wuhan, China
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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