Actively 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
Led by Shenzhen Ionova Life Sciences Co., Ltd. · Updated on 2025-12-17
84
Participants Needed
17
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 17 locations
1
Honor Health
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
Hoag Family Cancer Institute
Newport Beach, California, United States, 92663
Not Yet Recruiting
3
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
4
Next Oncology - Houston
Houston, Texas, United States, 77054
Actively Recruiting
5
UT Health
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
7
Summit Cancer Centers
Spokane, Washington, United States, 99208
Not Yet Recruiting
8
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Not Yet Recruiting
9
He'nan Cancer Hospital
Zhengzhou, He'Nan, China, 450000
Actively Recruiting
10
Hu'nan Cancer Hospital
Changsha, Hu'Nan, China, 410006
Not Yet Recruiting
11
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008
Actively Recruiting
12
Liaoning Cancer Hospital
Shenyang, Liaoning, China, 110801
Actively Recruiting
13
Shandong Cancer Hospital
Ji'nan, Shandong, China, 250000
Actively Recruiting
14
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Not Yet Recruiting
15
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300202
Actively Recruiting
16
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
17
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China, 310014
Not Yet Recruiting
Research Team
Y
Yi Zhu, MD, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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