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Recruiting NCT07230106

A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer

Phase II Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-20093 for Injection, SHR3680 Tablet, Abiraterone Tablet, SHR2554 Tablet.
Who it may be relevant to
Registry conditions: Prostate Cancer. Basic parameters: 18 years — 80 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics, and Efficacy of HS-20093 or SHR2554 Tablets in Combination With Novel Hormonal Agents in Participants With Metastatic Prostate Cancer

Overview

This is a phase II, multicentre clinical study investigating HS-20093 or SHR2554 in combination with a Novel Hormonal Agent (NHA) for advanced prostate cancer. The trial comprises two cohorts.

Interventions

  • Drug HS-20093 for Injection
    HS-20093 for injection.
  • Drug SHR3680 Tablet
    SHR3680 tablet.
  • Drug Abiraterone Tablet
    Abiraterone tablet.
  • Drug SHR2554 Tablet
    SHR2554 tablet.
  • Drug Enzalutamide Tablet
    Enzalutamide tablet.
  • Drug Darotamine Capsule
    Darotamine capsule.

Primary outcome measures

  • Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate. [Time frame: 6 months.]
  • Cohort 2: Prostate Specific Antigen (PSA) response rate. [Time frame: About 2 years.]
  • Cohort 2: Adverse events (AEs). [Time frame: About 2 years.]
  • Cohort 2: Dose-limiting toxicity (DLT). [Time frame: About 28 days.]
Secondary outcome measures (9)
  • Radiographic Progression-Free Survival (rPFS). [Time frame: About 2 years.]
  • Time to Prostate Specific Antigen (PSA) progression. [Time frame: About 2 years.]
  • Time to Next Symptomatic Skeletal Event (SSE). [Time frame: About 2 years.]
  • Time to Next Antineoplastic Therapy (TTNT). [Time frame: About 2 years.]
  • Objective response rate (ORR). [Time frame: About 2 years.]
  • Cohort 1: Adverse events (AEs). [Time frame: About 2 years.]
  • Disease control rate (DCR). [Time frame: About 2 years.]
  • Duration of response (DoR). [Time frame: About 2 years.]
  • Overall Survival (OS). [Time frame: About 2 years.]

Eligibility criteria

Inclusion criteria

  • Voluntarily participate in this clinical study, understand the research procedures, and are able to provide written informed consent.
  • Aged 18 to 80 years (inclusive), male.
  • ECOG performance status of 0 or 1.
  • Expected survival time ≥12 weeks.
  • Histologically or cytologically confirmed prostate adenocarcinoma, with no features of neuroendocrine carcinoma or small cell carcinoma.
  • Able to provide sufficient tumor tissue samples for retrospective genetic testing.
  • Ongoing Androgen Deprivation Therapy (ADT) throughout the study period, i.e., continuous treatment with a GnRH agonist or antagonist (chemical castration) or prior bilateral orchiectomy (surgical castration).
  • PSA level ≥1 ng/ml at screening.
  • Adequate organ function levels at baseline assessment.
  • Male participants with female partners of childbearing potential must agree to refrain from sperm donation and use effective contraception from the time of signing the informed consent form until 4.5 months after the last dose of HS-20093 or 3 months after the last dose of other study treatments, whichever is later.

Exclusion criteria

  • Known hypersensitivity or intolerance to the investigational drug(s) or their excipients.
  • Adverse events from prior anti-tumor therapy have not recovered to Grade ≤1 as per CTCAE v5.0.
  • Administration of estrogen, progesterone, or 5-alpha reductase inhibitors within 28 days prior to enrollment.
  • Administration of herbal medicines known to have anti-prostate cancer or PSA-lowering effects within 14 days prior to enrollment.
  • Major surgery within 28 days prior to enrollment; palliative radiotherapy within 14 days prior to enrollment; or traumatic minor surgery within 7 days prior to enrollment.
  • Pathological fractures in critical locations, spinal cord compression, etc., within the recent 6 months.
  • Non-healing wounds, untreated fractures, or severe bone damage due to metastatic disease.
  • Poorly controlled tumor-related pain.
  • Dysphagia or other conditions significantly affecting drug absorption.
  • Known central nervous system metastases or primary brain tumors.
  • Significant pericardial, pleural, or peritoneal effusion requiring intervention.
  • Severe cardiovascular or cerebrovascular diseases.
  • Moderate to severe pulmonary disease significantly affecting respiratory function.
  • Poorly controlled diabetes.
  • Serious active infections within 14 days prior to enrollment.
  • Active Hepatitis B, Hepatitis C, HIV, or immunodeficiency diseases.
  • History of other malignancies within 5 years prior to enrollment.
  • Any other condition deemed by the investigator to potentially affect the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 2 centers
  • Nanjing Drum Tower Hospital — Nanjing
  • Tianjin Medical University Cancer Institute and Hospital — Tianjin

Identifiers

NCT: NCT07230106 · SHR3680-205

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗