A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
Start Date
1/23/2025
Completion Date
1/17/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
INV-9956
Conditions
Locations
Honor Health
Scottsdale, Arizona 85258
United States
Hoag Family Cancer Institute
Newport Beach, California 92663
United States
UC Irvine Medical Center
Orange, California 92868
United States
Next Oncology - Houston
Houston, Texas 77054
United States
UT Health
San Antonio, Texas 78229
United States
NEXT Oncology
Fairfax, Virginia 22031
United States
Summit Cancer Centers
Spokane, Washington 99208
United States
Beijing GoBroad Hospital
Beijing, Beijing Municipality
China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian 350005
China
The First People's Hospital of Foshan
Foshan, Guangdong
China
He'nan Cancer Hospital
Zhengzhou, He'Nan 450000
China
Hu'nan Cancer Hospital
Changsha, Hu'Nan 410006
China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
China
Liaoning Cancer Hospital
Shenyang, Liaoning 110801
China
Shandong Cancer Hospital
Ji'nan, Shandong 250000
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality 200032
China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality 300202
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Hubei, Wuhan
China
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang 310003
China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang 310014
China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
China