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Tests treatment safety and results for Advanced Metastatic Castration Resistant Prostate Cancer
Official title A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
ClinicalTrials.gov ID: NCT06609005
What this study is testing
What is INV-9956?
INV-9956 is an investigational medicine, being studied as a potential treatment for advanced metastatic castration resistant prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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.
You likely can't join if
- Have a medical condition such as Crohn's disease or have undergone significant surgery to the gastrointestinal tract that could impair absorption or...
- 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...
- Active or unstable cardio-/cerebro-vascular disease, including thromboembolic events.
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Newport Beach, California, United States
- Orange, California, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Spokane, Washington, United States
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Foshan, Guangdong, China
- Zhengzhou, He'Nan, China
- Changsha, Hu'Nan, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Ji'nan, Shandong, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
- Hubei, Wuhan, China
- Hangzhou, Zhejiang, China
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Newport Beach, California, United States; Orange, California, United States; Houston, Texas, United States; San Antonio, Texas, United States; Fairfax, Virginia, United States and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.