NCT06609005 · Shenzhen Ionova Life Sciences Co., Ltd.
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer
What this study is about
This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC.
View original scientific description
This is a Phase 1 and Phase 2 study to determine the safety profile, RDR and/or MTD, DLT, PK/PD, and preliminary antitumor activity of INV-9956 in adult patients with advanced mCRPC.
Interventions
DRUG
INV-9956
INV-9956 is co-administered with dexamethasone and fludrocortisone acetate
Primary outcome measures
Phase 1: Maximum tolerated dose (MTD)
Time frame: Within first 28 days of treatment
The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.
Phase 1: Recommended dose range (RDR)
Time frame: 12 months
The RDR will be determined based on the PK and PD data, the preliminary clinical activity of INV-9956, as well as the incidence rate and nature of the toxicities observed in subsequent cycles beyond Cycle 1
Phase 2: Evaluate Radiographic progression-free survival (rPFS)
Time frame: 12 months
To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Phase 2: Evaluate overall response rate (ORR)
Time frame: 12 months
To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Scottsdale, Arizona
- Newport Beach, California
- Orange, California
- Houston, Texas
- San Antonio, Texas
- Fairfax, Virginia
- Spokane, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations