Evaluating INV-9956 for advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1a, first-in-human, open-label dose-escalation study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of INV-9956 in adult patients with advanced metastatic castration-resistant prostate cancer (mCRPC). The study will be conducted in three stages: initial dose escalation, followed by dose expansion, and an optional further dose escalation beyond the optimal dose. Patients will receive INV-9956 alongside corticosteroid replacement therapy with dexamethasone and fludrocortisone acetate.

Why it matters

Who can join: the full rules

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.

Where it's running

• Honor Health
  Scottsdale, Arizona, United States Recruiting
• Hoag Family Cancer Institute
  Newport Beach, California, United States Recruiting
• UC Irvine Medical Center
  Orange, California, United States Recruiting
• Next Oncology - Houston
  Houston, Texas, United States Recruiting
• UT Health
  San Antonio, Texas, United States Recruiting
• NEXT Oncology
  Fairfax, Virginia, United States Recruiting

Study contacts

• Study coordinator: Yi Zhu, MD, MBA
• Email: yi.zhu@ionovabio.com
• Phone: 1 908 240 7514

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.