AzTrials
AzTrials

Prostate CancerPhase 1/2NCT07407283

A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer

A Phase 1/2 study testing SHR-4394, Rezvilutamide and HRS-5041 Tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The study aims to assess the safety and tolerability of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer, and determine the recommended Phase II dose (RP2D); To evaluate of the efficacy of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer based on… Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
SHR-4394, Rezvilutamide and HRS-5041 Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesChina
Study dates
8 Apr 2026to Apr 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 85 years (inclusive) at the time of signing the informed consent form (with an upper age limit of 80 years for the dose escalation phase), and male.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy is expected to be at least 12 weeks.
  • Must have a prostate-specific antigen (PSA) level of ≥1 ng/mL during the screening period.
  • Ongoing therapy with a luteinizing hormone-releasing hormone analog (LHRHa) for medical castration or prior bilateral orchiectomy for surgical castration; participants who have not undergone bilateral orchiectomy must plan to maintain effective LHRHa therapy throughout the study period.
  • Must have histologically or cytologically confirmed prostate adenocarcinoma, without a diagnosis of neuroendocrine carcinoma or small cell carcinoma.
  • Must have radiographically confirmed metastatic disease by CT/MRI or radionuclide bone scan (⁹⁹ᵐTc).
  • Male participants with female partners of childbearing potential must practice highly effective contraception from the time of signing the informed consent form until 5 months after the last dose of the investigational product, and must refrain from donating sperm during this period.

Who cannot join

  • Planning to receive any other anti-tumor therapy during the course of this study.
  • Have received any other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first dose in this study.
  • Have undergone surgery requiring endotracheal intubation and general anesthesia within 28 days prior to the first dose, minor diagnostic or superficial surgery within 7 days prior to the first dose, or are scheduled to undergo elective surgery during the trial period.
  • Have not recovered from adverse events due to prior anti-tumor therapy to ≤ Grade 1 according to NCI-CTCAE v6.0 (with the exception of Grade 2 peripheral neuropathy, alopecia, hypothyroidism controlled with hormone replacement therapy, and well-controlled type 1 diabetes managed with insulin).
  • Known history of hypersensitivity to the investigational drug(s) to be used or any of their excipients.
  • Participants with untreated or inadequately treated central nervous system (CNS) metastases, or uncontrolled or symptomatic active CNS metastases are excluded. However, participants may be eligible if their CNS metastases have been adequately treated, and any neurological symptoms have resolved or been stable for at least 4 weeks prior to enrollment (residual signs or symptoms related to the CNS treatment are allowed).
Show all 18Show fewer
  • Uncontrolled tumor-related pain, as determined by the investigator. Participants requiring analgesic medication must be on a stable analgesic regimen at the time of study entry.
  • Presence of uncontrolled third-space effusions (e.g., pleural effusion, pericardial effusion, or ascites) that, despite therapeutic interventions such as drainage within 28 days prior to the first dose, remain uncontrolled or rapidly recur after drainage, requiring repeated drainage procedures.
  • History of any other malignancy within 5 years prior to the first dose, with the exception of adequately treated basal cell or squamous cell carcinoma of the skin, radically resected papillary thyroid carcinoma, and radically resected ductal carcinoma in situ of the breast.
  • History of epilepsy or any condition predisposing to seizures (such as transient ischemic attack, stroke, or traumatic brain injury with loss of consciousness requiring hospitalization) within 12 months prior to enrollment.
  • History of interstitial pneumonia (ILD) or interstitial lung disease (including cases requiring steroid therapy), or any other history of pulmonary fibrosis, organizing pneumonia, drug- or radiation-induced pneumonitis, congenital pneumonitis, or any evidence of active pneumonia on chest CT scan that may interfere with the assessment of immune-related pulmonary toxicity.
  • Active severe gastrointestinal disorders, including but not limited to complete or incomplete bowel obstruction, persistent/recurrent diarrhea (or diarrhea with fever), moderate to severe gastrointestinal hemorrhage (including endoscopically active bleeding), gastric or duodenal ulcers, gastrointestinal perforation, acute pancreatitis, ulcerative colitis, congenital megacolon, Crohn's disease, etc.
  • Exclusion is required for: a history of severe infection within 4 weeks prior to the first dose; active infection requiring systemic antibiotics within 2 weeks prior to the first dose; or evidence of active tuberculosis infection within 1 year prior to enrollment. A history of active tuberculosis (TB) infection more than 1 year ago without adequate treatment is also excluded.
  • Active hepatitis B virus or hepatitis C virus (HBV/HCV) infection (HBsAg+ with DNA ≥ 2000 IU/mL; HCV Ab+ with RNA > ULN).
  • Participants are excluded if they have a history of immunodeficiency (including HIV positivity, other acquired or congenital immunodeficiencies) or organ transplantation, or a history of active autoimmune disease. Exceptions include participants with immune disorders not requiring systemic treatment (e.g., vitiligo, psoriasis) or autoimmune conditions well-controlled by hormone replacement therapy (e.g., type 1 diabetes, hypothyroidism).
  • History of severe cardiovascular or cerebrovascular disease.
  • History of arterial or venous thromboembolic events within 3 months prior to the first dose, or the presence of arterial/venous thrombosis (e.g., deep vein thrombosis, pulmonary embolism) identified during screening.
  • Any concomitant illness, condition, or social circumstance that, in the judgment of the investigator, could compromise participant safety or interfere with the completion of the study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yue Cheng contact

+86-0518-81220121

yue.cheng.yc50@hengrui.com

China2 sites, 2 recruiting

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

    Qiang Wei, +86-18980601425, wq933@hotmail.com

    Qiang Dong, +86-18980601367, dqiang@gmail.com

    Recruiting

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

    Yuanjie Niu, +86-13821827881, Niuyuanjie9317@163.com

    Yuanjie Niu

    Recruiting

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of SHR-4394 in Combination With Anti-tumor Therapy in Participants With Prostate Cancer

The study aims to assess the safety and tolerability of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer, and determine the recommended Phase II dose (RP2D); To evaluate of the efficacy of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer based on Prostate-Specific Antigen (PSA) response rate.

Conditions
Prostate Cancer
Being tested
SHR-4394, Rezvilutamide, HRS-5041 Tablets, Tazemetostat
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SHR-4394Drug

    SHR-4394.

  • RezvilutamideDrug

    Rezvilutamide tablets.

  • HRS-5041 TabletsDrug

    HRS-5041 tablets.

  • TazemetostatDrug

    Tazemetostat tablets.

Study groups in NCT07407283
Study groupRoleWhat they receive
SHR-4394 in combination with anti-tumor therapy GroupExperimentalSHR-4394, Rezvilutamide, HRS-5041, Tazemetostat.
Receives: Drug: SHR-4394; Drug: Rezvilutamide; Drug: HRS-5041 Tablets; Drug: Tazemetostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D) of SHR-4394 combined with anti-tumor therapy in prostate cancer participants

    Phase I.

    Measured: About 12 months.

  2. The incidence and severity of adverse events (AEs)

    Phase I.

    Measured: About 12 months.

  3. Prostate-Specific Antigen response rate (PSA50)

    Phase II.

    Measured: About 16 months.

Secondary outcomes (11)

  1. Objective Response Rate (ORR)

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  2. Disease Control Rate (DCR)

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  3. Duration of Response (DoR)

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  4. Prostate-Specific Antigen (PSA) Response Rate

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  5. Time to PSA progression

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  6. Radiographic Progression-Free Survival (rPFS)

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  7. Overall Survival (OS)

    Efficacy endpoints of SHR-4394 in combination with anti-tumor therapy in participants with prostate cancer.

    Measured: About 28 months.

  8. Plasma concentrations of SHR-4394 and its combination drugs

    Phase I.

    Measured: About 12 months.

  9. Prostate-Specific Antigen response rate (PSA90)

    Phase II.

    Measured: About 28 months.

  10. Proportion of participants with undetectable PSA

    Phase II.

    Measured: About 6 months.

  11. Incidence and severity of adverse events (AEs)

    Phase II.

    Measured: About 16 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start8 Apr 2026
  3. Primary completionNov 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
SHR-4394 in combination with anti-tumor therapy.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07407283
Sponsor's protocol ID
SHR-4394-201
Status last verified
Apr 2026
First submitted
6 Feb 2026
Last updated
21 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR-4394, Rezvilutamide and HRS-5041 Tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yue Cheng (+86-0518-81220121, yue.cheng.yc50@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) of SHR-4394 combined with anti-tumor therapy in prostate cancer participants (time frame: About 12 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07407283.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in