Testing INV-9956 in adults with advanced prostate cancer
Tests INV-9956 in adults with advanced prostate cancer that has spread.
Plain-language title generated from the registry record
Registry 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
Key facts
- Where
- Beijing, Changsha, Foshan, Fuzhou, Hangzhou, Hubei, Ji'nan, Nanchang, Nanjing, Shanghai, Shenyang, Tianjin, Wenzhou, and Zhengzhou, ChinaSee the 15 sites
- Phase
- Phase 1/2
Where in China
- Beijing GoBroad HospitalBeijing, ChinaNot yet recruiting
- Hu'nan Cancer HospitalChangsha, ChinaNot yet recruiting
- The First People's Hospital of FoshanFoshan, ChinaNot yet recruiting
- The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaTaking people
- The first Affiliated Hospital, School of Medicine, Zhejiang University.Hangzhou, ChinaTaking people
- Zhejiang Provincial People's HospitalHangzhou, ChinaNot yet recruiting
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyHubei, ChinaNot yet recruiting
- Shandong Cancer HospitalJi'nan, ChinaTaking people
- The First Affiliated Hospital of NanChang UniversityNanchang, ChinaNot yet recruiting
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
- Liaoning Cancer HospitalShenyang, ChinaTaking people
- Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaNot yet recruiting
- He Nan Cancer HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shenzhen Ionova Life Sciences Co., Ltd.
- Trial code
- NCT06609005
- Record updated
- 4 June 2026
- Original 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.Read full original descriptionShow less
A Phase 1 and Phase 2, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Evidence of Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
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.
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: History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment; 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; 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; Active infection or other medical condition that would make corticosteroid contraindicated; Clinically significant abnormality in serum potassium and sodium; Prolonged QTcF interval.