Actively Recruiting
Phase 1 and 2 Study of INV-9956 with Dexamethasone and Fludrocortisone Acetate for Adult Men with Advanced Metastatic Castration Resistant Prostate Cancer
Led by Shenzhen Ionova Life Sciences Co., Ltd. · Updated on 2026-06-04
84
Participants Needed
22
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and antitumor activity of the drug INV-9956 in adult men with advanced metastatic castration resistant prostate cancer. This study is conducted in two parts Phase 1 focuses on finding the right dose and assessing safety, while Phase 2 aims to confirm safety and explore how well the drug works in patients with different androgen receptor gene statuses. Participants receive INV-9956 along with dexamethasone and fludrocortisone acetate. In Phase 1, dose levels are gradually increased using a careful monitoring process to find the maximum tolerated dose and recommended dose range. Phase 2 includes two groups one with mutated androgen receptor cancer and one with wild-type androgen receptor cancer, to further evaluate the drugs effects. During the study, participants will undergo various assessments including safety evaluations, blood tests for drug concentration and hormone levels, and imaging to track cancer progression. The main outcomes measured are maximum tolerated dose, radiographic progression-free survival, and overall response rate over 12 months. The study also monitors side effects and drug behavior in the body to better understand treatment effects and safety.
CONDITIONS
Brief 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
Research Team
Y
Yi Zhu, MD, MBA
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
