Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Edward Uchio, MD

Description

Summary

This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC.

Official Title

A Phase 1, 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

Details

This is a Phase 1a, first-in-human, open-label dose-escalation study to determine the RDR and/or MTD, and to assess the DLT of INV-9956. The safety, tolerability, PK/PD, and preliminary antitumor activity of INV-9956 will be assessed in adult patients with advanced mCRPC. The study will be conducted in 3 stages: Stage 1: dose escalation; Stage 2: dose expansion; Stage 3 (optional): Dose escalation beyond the optimal dose.

The total number of patients enrolled will depend upon the number of dose-escalation cohorts and the number of doses evaluated in Stage 2.

The investigational drug will be co-administered with dexamethasone and fludrocortisone acetate as corticosteroid replacement therapy.

Keywords

Advanced Metastatic Castration Resistant Prostate Cancer, mCRPC, Prostate Cancer, Prostatic Neoplasms, INV-9956

Eligibility

You can join if…

Open to males ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • UC Irvine Medical Center not yet accepting patients
    Orange California 92868 United States
  • Hoag Family Cancer Institute not yet accepting patients
    Newport Beach California 92663 United States
  • Honor Health accepting new patients
    Scottsdale Arizona 85258 United States
  • UT Health accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at UC Irvine

  • Edward Uchio, MD
    Clinical Professor, Urology, School of Medicine. Authored (or co-authored) 83 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Shenzhen Ionova Life Sciences Co., Ltd.
ID
NCT06609005
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 66 study participants
Last Updated