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New hope for Hard-to-Treat prostate cancer? early trial launches

NCT ID NCT06609005

Disease control Sponsor: Shenzhen Ionova Life Sciences Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called INV-9956 in 84 men with advanced prostate cancer that has spread and stopped responding to hormone therapy and chemotherapy. The goal is to find a safe dose and see if the drug can shrink tumors or slow the disease. Participants take INV-9956 along with two other medicines to manage side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
INV-9956 (given with dexamethasone and fludrocortisone acetate)
What this could lead to
If it works, this could offer a new treatment option for men with advanced prostate cancer that has stopped responding to standard therapies.
What could go wrong
This is an early-phase trial with only 84 participants, so the drug may not prove effective or may have unexpected side effects. It is not a cure and long-term benefits are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 84 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced metastatic castration-resistant prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing GoBroad Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • He'nan Cancer Hospital

    RECRUITING

    Zhengzhou, He'Nan, 450000, China

  • Hoag Family Cancer Institute

    RECRUITING

    Newport Beach, California, 92663, United States

    Contact Email: •••••@•••••

  • Honor Health

    RECRUITING

    Scottsdale, Arizona, 85258, United States

    Contact Email: •••••@•••••

  • Hu'nan Cancer Hospital

    NOT_YET_RECRUITING

    Changsha, Hu'Nan, 410006, China

  • Liaoning Cancer Hospital

    RECRUITING

    Shenyang, Liaoning, 110801, China

  • NEXT Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Next Oncology - Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • Shandong Cancer Hospital

    RECRUITING

    Ji'nan, Shandong, 250000, China

  • Summit Cancer Centers

    RECRUITING

    Spokane, Washington, 99208, United States

  • The First Affiliated Hospital of Fujian Medical University

    RECRUITING

    Fuzhou, Fujian, 350005, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, China

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

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First People's Hospital of Foshan

    NOT_YET_RECRUITING

    Foshan, Guangdong, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300202, China

  • UC Irvine Medical Center

    RECRUITING

    Orange, California, 92868, United States

  • UT Health

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Hubei, Wuhan, China

  • Zhejiang Provincial People's Hospital

    NOT_YET_RECRUITING

    Hangzhou, Zhejiang, 310014, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.