RecruitingPhase 1Phase 2NCT06609005
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
Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
Enrollment
84 participants
Start Date
Jan 23, 2025
Study Type
INTERVENTIONAL
Conditions
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
Sex: MALEMin Age: 18 Years
Inclusion Criteria12
- Written informed consent obtained.
- Male aged ≥ 18 years.
- Histologically confirmed adenocarcinoma of the prostate.
- Castration resistant prostate cancer with serum testosterone \<50 ng/dL.
- Metastatic disease.
- Ongoing androgen deprivation therapy with GnRH analogue or antagonist, or have had bilateral orchiectomy.
- 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.
- ECOG performance status 0-1.
- Adequate marrow, liver and kidney function.
- INR ≤1.5.
- Able to swallow study treatment.
- Has a life expectancy of \> 3 months.
Exclusion Criteria9
- 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.
- History of pituitary or adrenal dysfunction.
- Poorly controlled diabetes mellitus.
- Clinically significant abnormality in serum potassium and sodium.
- 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.
- Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
- History of congestive heart failure; cardiac disease, myocardial infarction within 6 months prior to enrollment.
- Prolonged QTcF interval.
- Active infection or other medical condition that would make corticosteroid contraindicated.
Interventions
DRUGINV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Locations(17)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06609005