RightFit
RecruitingPhase 1 / Phase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 1 and 2 study tests INV-9956 for safety and its ability to fight prostate cancer. It also studies how the body handles the drug and how the drug affects the body. It is for adult men whose prostate cancer has spread and keeps growing despite very low testosterone levels.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men age 18 or older who give written consent to join.
  • Have prostate adenocarcinoma, a type of cancer confirmed by a tissue test, that has spread.
  • Cancer keeps growing despite a blood testosterone level below 50 ng/dL.
  • Still receive medicine to lower testosterone, or have had both testicles removed.
  • Have had at least one taxane chemotherapy treatment and one hormone-targeted treatment, such as abiraterone or enzalutamide. Men who refused or could not tolerate taxane chemotherapy may also join.
  • Can do all or most daily activities, with only limits on hard physical activity.
  • Have good enough bone marrow, liver, and kidney function, and an INR blood-clotting test result of 1.5 or less.
  • Can swallow the study treatment and are expected to live more than 3 months.

Who can't join

  • Have a gut condition, such as Crohn's disease, or major gut surgery that could keep the body from absorbing medicine properly.
  • Have a history of problems with the pituitary or adrenal glands, which make hormones.
  • Have poorly controlled diabetes or important changes in blood potassium or sodium levels.
  • Have a serious illness other than cancer that the study doctor or sponsor thinks could interfere with the study, such as liver failure or kidney swelling from backed-up urine.
  • Have active or unstable disease of the heart or blood vessels, including those in the brain, or blood clots.
  • Have a history of heart failure, heart disease, or a heart attack within 6 months before joining.
  • Have a prolonged QTcF interval, a heart test finding that means the heart takes longer to reset between beats.
  • Have an active infection or another condition that makes corticosteroid medicines unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \<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.

Study sites (7)

AZ

CA

TX

VA

WA