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NCT06609005PHASE1, PHASE2Recruiting

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

Shenzhen Ionova Life Sciences Co., Ltd.

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

Inclusion Criteria: 1. Written informed consent obtained. 2. Male aged ≥ 18 years. 3. Histologically confirmed adenocarcinoma of the prostate. 4. Castration resistant prostate cancer with serum testosterone \<50 ng/dL. 5. Metastatic disease. 6. Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy. 7. Received at least one prior line of taxane-based chemotherapy and at least one line of hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who have refused or were intolerant to taxane-based chemotherapy may be enrolled. 8. ECOG performance status 0-1. 9. Adequate marrow, liver and kidney function. 10. INR ≤1.5. 11. Able to swallow study treatment. 12. Has a life expectancy of \> 3 months. Exclusion Criteria: 1. Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or that could result in short bowel syndrome with diarrhea due to malabsorption. 2. History of pituitary or adrenal dysfunction. 3. Poorly controlled diabetes mellitus. 4. Clinically significant abnormality in serum potassium and sodium. 5. Have a serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. 6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events. 7. History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment. 8. Prolonged QTcF interval. 9. Active infection or other medical condition that would make corticosteroid contraindicated.

Interventions

DRUG

INV-9956

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Conditions

Advanced Metastatic Castration Resistant Prostate Cancer

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