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 · NCT06609005 · Interventional (participants receive a specific treatment) · Lead sponsor: Shenzhen Ionova Life Sciences Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
INV-9956
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.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
22 locations listed across 5 US states.
- 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
- Beijing GoBroad Hospital - Beijing, Beijing Municipality, China
- The First Affiliated Hospital of Fujian Medical University - Fuzhou, Fujian, China
- The First People's Hospital of Foshan - Foshan, Guangdong, China
- He'nan Cancer Hospital - Zhengzhou, He'Nan, China
- Hu'nan Cancer Hospital - Changsha, Hu'Nan, China
- Nanjing Drum Tower Hospital - Nanjing, Jiangsu, China
- The First Affiliated Hospital of Nanchang University - Nanchang, Jiangxi, 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
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology - Hubei, Wuhan, China
- The First Affiliated Hospital, School of Medicine, Zhejiang University - Hangzhou, Zhejiang, China
- Zhejiang Provincial People's Hospital - Hangzhou, Zhejiang, China
- The First Affiliated Hospital of Wenzhou Medical University - Wenzhou, Zhejiang, China