A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

Last updated: December 14, 2025
Sponsor: Shenzhen Ionova Life Sciences Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Urologic Cancer

Prostate Disorders

Prostate Cancer

Treatment

INV-9956

Clinical Study ID

NCT06609005
INV-9956-101
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 hadbilateral orchiectomy.

  7. Received at least one prior line of taxane-based chemotherapy and at least one lineof hormonal AR targeted therapy (eg, abiraterone, enzalutamide). Patients who haverefused 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

Exclusion Criteria:

  1. Have a medical condition such as Crohn's disease or have undergone significantsurgery to the gastrointestinal tract that could impair absorption or that couldresult 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 otherconditions) that could compromise protocol objectives in the opinion of theInvestigator and/or the Sponsor.

  6. Active or unstable cardio-/cerebro-vascular disease, including thromboembolicevents.

  7. History of congestive heart failure; cardiac disease, myocardial infarction within 6months prior to enrollment.

  8. Prolonged QTcF interval.

  9. Active infection or other medical condition that would make corticosteroidcontraindicated.

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: INV-9956
Phase: 1/2
Study Start date:
January 23, 2025
Estimated Completion Date:
January 17, 2028

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou 1810821, Fujian 1811017 350005
    China

    Site Not Available

  • He'nan Cancer Hospital

    Zhengzhou 1784658, He'Nan 450000
    China

    Active - Recruiting

  • Hu'nan Cancer Hospital

    Changsha 1815577, Hu'Nan 410006
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang 2034937, Liaoning 2036115 110801
    China

    Active - Recruiting

  • Shandong Cancer Hospital

    Ji'nan, Shandong 1796328 250000
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, Shanghai Municipality 1796231 200032
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300202
    China

    Active - Recruiting

  • The First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Active - Recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou 1808926, Zhejiang 1784764 310014
    China

    Site Not Available

  • Honor Health

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Honor Health

    Scottsdale 5313457, Arizona 5551752 85258
    United States

    Active - Recruiting

  • Hoag Family Cancer Institute

    Newport Beach, California 92663
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange, California 92868
    United States

    Site Not Available

  • Hoag Family Cancer Institute

    Newport Beach 5376890, California 5332921 92663
    United States

    Site Not Available

  • UC Irvine Medical Center

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • Next Oncology - Houston

    Houston, Texas 77054
    United States

    Site Not Available

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Site Not Available

  • UT Health

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Next Oncology - Houston

    Houston 4699066, Texas 4736286 77054
    United States

    Active - Recruiting

  • UT Health

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • NEXT Oncology

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • NEXT Oncology

    Fairfax 4758023, Virginia 6254928 22031
    United States

    Active - Recruiting

  • Summit Cancer Centers

    Spokane, Washington 99208
    United States

    Site Not Available

  • Summit Cancer Centers

    Spokane 5811696, Washington 5815135 99208
    United States

    Site Not Available

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