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New treatment option for Prostate Cancer
Official title A Clinical Study of SHR-4394 in Combination With Anti-tumor Therapy in Prostate Cancer
ClinicalTrials.gov ID: NCT07407283
What this study is testing
What is SHR-4394?
SHR-4394 is an investigational medicine, being studied as a potential treatment for prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- 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)...
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility criteria
Who can 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.