A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
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
1 other identifier
interventional
218
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 prostate-cancer
Started Dec 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2025
CompletedFirst Posted
Study publicly available on registry
November 17, 2025
CompletedStudy Start
First participant enrolled
December 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
March 3, 2026
November 1, 2025
3 years
November 13, 2025
February 28, 2026
Conditions
Outcome Measures
Primary Outcomes (4)
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.
6 months.
Cohort 2: Prostate Specific Antigen (PSA) response rate.
About 2 years.
Cohort 2: Adverse events (AEs).
About 2 years.
Cohort 2: Dose-limiting toxicity (DLT).
About 28 days.
Secondary Outcomes (9)
Radiographic Progression-Free Survival (rPFS).
About 2 years.
Time to Prostate Specific Antigen (PSA) progression.
About 2 years.
Time to Next Symptomatic Skeletal Event (SSE).
About 2 years.
Time to Next Antineoplastic Therapy (TTNT).
About 2 years.
Objective response rate (ORR).
About 2 years.
- +4 more secondary outcomes
Study Arms (2)
Cohort 1 Group
EXPERIMENTALCohort 2 Group
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2025
First Posted
November 17, 2025
Study Start
December 8, 2025
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
March 3, 2026
Record last verified: 2025-11