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Recruiting 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

Conditions: Advanced Metastatic Castration Resistant Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 84
Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.

Location: Honor Health Scottsdale Arizona

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.

Eligibility Criteria

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 \ 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06609005). StuddyBuddy aggregates publicly available trial information.