A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Part of paid clinical trials in Scottsdale, Arizona.
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
- Study ID
- NCT06609005
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Advanced Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- INV-9956 — DRUGINV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Study Details
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.
Key Dates
- Start date
- Jan 23, 2025
- Status verified
- Jun 2026
- Primary completion
- Jan 17, 2028
- Completion
- Jan 17, 2028
Study Design
- Enrollment
- 84 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Phase 1 INV-9956 Dose escalation Dose level 1INV-9956 Dose escalation Dose level 1 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 1 INV-9956 Dose escalation Dose level 2INV-9956 Dose escalation Dose level 2 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 1 INV-9956 Dose escalation Dose level 3INV-9956 Dose escalation Dose level 3 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 2 INV-9956 Dose expansion - Cohort AINV-9956 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 2 INV-9956 Dose expansion - Cohort BINV-9956 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 4INV-9956 Dose escalation Dose level 4 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 5INV-9956 Dose escalation Dose level 5 is co-administered with dexamethasone and fludrocortisone acetate
- Experimental: Phase 1 INV-9956 Dose escalation beyond the optimal dose - Dose level 6INV-9956 Dose escalation Dose level 6 is co-administered with dexamethasone and fludrocortisone acetate
Primary Outcome Measure
Phase 1: Maximum tolerated dose (MTD) [ Time Frame: Within first 28 days of treatment ]
Central Contacts
- Yi Zhu, MD, MBA1 908 240 7514
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Honor Health | Scottsdale | Arizona | 85258 | Andrea House Michael Gordon, MD (PRINCIPAL_INVESTIGATOR) |
| Hoag Family Cancer Institute | Newport Beach | California | 92663 | David Benjamin, MD (PRINCIPAL_INVESTIGATOR) |
| UC Irvine Medical Center | Orange | California | 92868 | Edward Uchio, MD (PRINCIPAL_INVESTIGATOR) |
| Next Oncology - Houston | Houston | Texas | 77054 | Peter DeMaria, MD (PRINCIPAL_INVESTIGATOR) |
| UT Health | San Antonio | Texas | 78229 | John Sarantopoulos, MD (PRINCIPAL_INVESTIGATOR) |
| NEXT Oncology | Fairfax | Virginia | 22031 | Mohamed Salkeni, MD (PRINCIPAL_INVESTIGATOR) |
| Summit Cancer Centers | Spokane | Washington | 99208 | Arvind Chaudhry, MD, PhD (PRINCIPAL_INVESTIGATOR) |