Evaluating INV-9956 for advanced 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

This study is testing a new drug called INV-9956 to see if it can safely help adults with advanced prostate cancer that doesn't respond to hormone therapy.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 17 sites (Scottsdale, Arizona and 16 other locations)
• Trial ID: NCT06609005 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adult males aged 18 and older with histologically confirmed adenocarcinoma of the prostate who have advanced metastatic castration-resistant disease.

Not a fit: Patients with significant gastrointestinal conditions that impair drug absorption or those who have undergone major gastrointestinal surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced mCRPC.

How similar studies have performed: While this approach is novel, similar studies targeting advanced prostate cancer have shown promise in the past.

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.

Where this trial is running

Scottsdale, Arizona and 16 other locations

• Honor Health — Scottsdale, Arizona, United States (Recruiting)
• Hoag Family Cancer Institute — Newport Beach, California, United States (Not_yet_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)
• Summit Cancer Centers — Spokane, Washington, United States (Not_yet_recruiting)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• He'nan Cancer Hospital — Zhengzhou, He'Nan, China (Recruiting)
• Hu'nan Cancer Hospital — Changsha, Hu'Nan, China (Not_yet_recruiting)
• Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Recruiting)
• Shandong Cancer Hospital — Ji'nan, Shandong, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• The First Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yi Zhu, MD, MBA

Conditions Advanced Metastatic Castration Resistant Prostate Cancer; mCRPC; Prostate Cancer