NCT06609005

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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. The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion. Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment. Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status: * Cohort A: AR mutant CRPC * Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.

Conditions

• Advanced Metastatic Castration Resistant Prostate Cancer

Interventions

Type	Name	Description
DRUG	INV-9956	INV-9956 is co-administered with dexamethasone and fludrocortisone acetate

Timeline

• Start date: 2025-01-23
• Primary completion: 2026-04-17
• Completion: 2028-01-17
• First posted: 2024-09-23
• Last updated: 2025-12-17

Locations

17 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study