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
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
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)
- Phase 1: Maximum tolerated dose (MTD) — Within first 28 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT. - Phase 1: Recommended dose range (RDR) — 12 months
The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-9956, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1 - Phase 2: Evaluate Radiographic progression-free survival (rPFS) — 12 months
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases) - Phase 2: Evaluate overall response rate (ORR) — 12 months
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Trial sites (22)
| Facility | City | Region | Status |
|---|---|---|---|
| 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