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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.
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.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Honor Health
Scottsdale, Arizona, United States
Hoag Family Cancer Institute
Newport Beach, California, United States
UC Irvine Medical Center
Orange, California, United States
Next Oncology - Houston
Houston, Texas, United States
UT Health
San Antonio, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Summit Cancer Centers
Spokane, Washington, United States
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
He'nan Cancer Hospital
Zhengzhou, He'Nan, China
Hu'nan Cancer Hospital
Changsha, Hu'Nan, China
Start Date
January 23, 2025
Primary Completion Date
April 17, 2026
Completion Date
January 17, 2028
Last Updated
December 17, 2025
84
ESTIMATED participants
INV-9956
DRUG
Lead Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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