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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT06609005Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.Last updated: 2026-06-04

Summary

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.

Detailed description

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. The entire study consists of two parts: Phase 1 for dose escalation and Phase 2 for dose expansion. Phase 1 dose escalation of INV-9956 follows a real time monitored, PK/PD and safety guided scheme with a traditional 3+3 design for DLT assessment. Phase 2 aims to reassure the safety profile and better define efficacy. Phase 2 consists of up to 2 cohorts by different AR gene status: * Cohort A: AR mutant CRPC * Cohort B: AR wide-type CRPC (optional) Currently enrolling patients under Phase 2.

Arms & interventions

  • DrugINV-9956

    INV-9956 is co-administered with dexamethasone and fludrocortisone acetate

Outcome measures

Primary

  • Phase 1: Maximum tolerated dose (MTD)

    The highest dose level at which at least 6 patients have been treated and less than 33% of patients experienced a DLT.

    Time frame: Within first 28 days of treatment

  • Phase 1: Recommended dose range (RDR)

    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

    Time frame: 12 months

  • Phase 2: Evaluate Radiographic progression-free survival (rPFS)

    To evaluate rPFS per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)

    Time frame: 12 months

  • Phase 2: Evaluate overall response rate (ORR)

    To evaluate ORR per PCWG-modified RECIST v1.1 (soft tissue response) and PCWG3 criteria (bone metastases)

    Time frame: 12 months

Secondary

  • Phase 1: Characterize the safety of INV-9956 as assessed by CTCAE v5.0

    Time frame: 12 months

  • Phase 1: Determine the PK using AUC of INV-9956

    Time frame: 12 months

  • Phase 1: Determine the PK using Cmax of INV-9956

    Time frame: 12 months

  • Phase 1: Determine the blood concentration of steroid hormone

    Time frame: 12 months

  • Phase 1: Evaluate Radiographic progression-free survival (rPFS)

    Time frame: 12 months

  • Phase 1: Evaluate overall response rate (ORR)

    Time frame: 12 months

  • Phase 2: Characterize the safety of INV-9956 as assessed by CTCAE v5.0

    Time frame: 12 months

  • Phase 2: Determine the PK using AUC of INV-9956

    Time frame: 12 months

  • Phase 2: Determine the PK using Cmax of INV-9956

    Time frame: 12 months

  • Phase 2: Determine the blood concentration of steroid hormone

    Time frame: 12 months

Eligibility criteria

Sex: MaleAge: 18 Years and olderHealthy volunteers: No
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 locations (7)

Honor Health

Scottsdale, Arizona, 85258

Recruiting
Andrea House · Contact
Michael Gordon, MD · Principal Investigator

Hoag Family Cancer Institute

Newport Beach, California, 92663

Recruiting
Patrice Jones · Contact
David Benjamin, MD · Principal Investigator

UC Irvine Medical Center

Orange, California, 92868

Recruiting
Hazel Dimasuay · Contact
Edward Uchio, MD · Principal Investigator

Next Oncology - Houston

Houston, Texas, 77054

Recruiting
Peter DeMaria, MD · Principal Investigator

UT Health

San Antonio, Texas, 78229

Recruiting
Epp Goodwin · Contact
John Sarantopoulos, MD · Principal Investigator

NEXT Oncology

Fairfax, Virginia, 22031

Recruiting
Blake Patterson · Contact
Mohamed Salkeni, MD · Principal Investigator

Summit Cancer Centers

Spokane, Washington, 99208

Recruiting
Arvind Chaudhry, MD, PhD · Principal Investigator
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer | Cancerify