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Clinical Trials in China / NCT06609005
Recruiting Phase 1/2

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

NCT06609005 · tracked via the Priya Life Science China tracker
Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Phase
Phase 1/2
Started
2025-01-23
Last updated
2026-06-04

Condition(s) studied

Advanced Metastatic Castration Resistant Prostate Cancer

Investigational drug(s) / intervention(s)

INV-9956

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

Study 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
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Written informed consent obtained. 2. Male aged ≥ 18 years. 3. Histologically confirmed adenocarcinoma of the prostate. 4. Castration resistant prostate cancer with serum testosterone \<50 ng/dL. 5. Metastatic disease. 6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy. 7. 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. 8. ECOG performance status 0-1. 9. Adequate marrow, liver and kidney function. 10. INR ≤1.5. 11. Able to swallow study treatment. 12. Has a life expectancy of \> 3 months. Exclusion Criteria: 1. 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. 2. History of pituitary or adrenal dysfunction. 3. Poorly controlled diabetes mellitus. 4. Clinically significant abnormality in serum potassium and sodium. 5. 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. 6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events. 7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment. 8. Prolonged QTcF interval. 9. Active infection or other medical condition that would make corticosteroid contraindicated.

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Honor Health Scottsdale Arizona Recruiting
Hoag Family Cancer Institute Newport Beach California Recruiting
UC Irvine Medical Center Orange California Recruiting
Next Oncology - Houston Houston Texas Recruiting
UT Health San Antonio Texas Recruiting
NEXT Oncology Fairfax Virginia Recruiting
Summit Cancer Centers Spokane Washington Recruiting
Beijing GoBroad Hospital Beijing Beijing Municipality Not Yet Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting
The First People's Hospital of Foshan Foshan Guangdong Not Yet Recruiting
He'nan Cancer Hospital Zhengzhou He'Nan Recruiting
Hu'nan Cancer Hospital Changsha Hu'Nan Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Not Yet Recruiting
Liaoning Cancer Hospital Shenyang Liaoning Recruiting
Shandong Cancer Hospital Ji'nan Shandong Recruiting
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Hubei Wuhan Not Yet Recruiting
The First Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang Recruiting
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Not Yet Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Not Yet Recruiting

More Shenzhen Ionova Life Sciences Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06609005 on ClinicalTrials.gov ↗ ← All trials in China