Status:
RECRUITING
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Lead Sponsor:
Shenzhen Ionova Life Sciences Co., Ltd.
Conditions:
Advanced Metastatic Castration Resistant Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed Description
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. The entire study consist...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 17 2028
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT06609005
Start Date
January 23 2025
End Date
January 17 2028
Last Update
December 17 2025
Active Locations (17)
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1
Honor Health
Scottsdale, Arizona, United States, 85258
2
Hoag Family Cancer Institute
Newport Beach, California, United States, 92663
3
UC Irvine Medical Center
Orange, California, United States, 92868
4
Next Oncology - Houston
Houston, Texas, United States, 77054