Prostate CancerPhase 2NCT07230106
A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer
A Phase 2 study testing HS-20093 for Injection, SHR3680 Tablet and Abiraterone Tablet in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- HS-20093 for Injection, SHR3680 Tablet and Abiraterone Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesChina
- Study dates
- 8 Dec 2025to Dec 2029
- Phase
- Phase 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210009
Hongqian Guo, 025-68182869, gymwpi@126.com
Hongqian Guo
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Xin Yao, 022-23340123 ext. 2131, yaoxin@tjmuch.com
Xin Yao
About this study
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
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.
- Conditions
- Prostate Cancer
- Being tested
- HS-20093 for Injection, SHR3680 Tablet, Abiraterone Tablet, SHR2554 Tablet, Enzalutamide Tablet
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-20093 for InjectionDrug
HS-20093 for injection.
SHR3680 TabletDrug
SHR3680 tablet.
Abiraterone TabletDrug
Abiraterone tablet.
SHR2554 TabletDrug
SHR2554 tablet.
Enzalutamide TabletDrug
Enzalutamide tablet.
Darotamine CapsuleDrug
Darotamine capsule.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 Group | Experimental | Not described Receives: Drug: HS-20093 for Injection; Drug: SHR3680 Tablet; Drug: Abiraterone Tablet |
| Cohort 2 Group | Experimental | Not described Receives: Drug: SHR3680 Tablet; Drug: SHR2554 Tablet; Drug: Enzalutamide Tablet; Drug: Darotamine Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate.
Measured: 6 months.
Cohort 2: Prostate Specific Antigen (PSA) response rate.
Measured: About 2 years.
Cohort 2: Adverse events (AEs).
Measured: About 2 years.
Cohort 2: Dose-limiting toxicity (DLT).
Measured: About 28 days.
Secondary outcomes (9)
Radiographic Progression-Free Survival (rPFS).
Measured: About 2 years.
Time to Prostate Specific Antigen (PSA) progression.
Measured: About 2 years.
Time to Next Symptomatic Skeletal Event (SSE).
Measured: About 2 years.
Time to Next Antineoplastic Therapy (TTNT).
Measured: About 2 years.
Objective response rate (ORR).
Measured: About 2 years.
Cohort 1: Adverse events (AEs).
Measured: About 2 years.
Disease control rate (DCR).
Measured: About 2 years.
Duration of response (DoR).
Measured: About 2 years.
Overall Survival (OS).
Measured: About 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start8 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230106
- Sponsor's protocol ID
- SHR3680-205
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07230106
- Acronym / sponsor ID
- SHR3680-205
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 Group | Experimental | Drug: HS-20093 for Injection, Drug: SHR3680 Tablet, Drug: Abiraterone Tablet |
| Cohort 2 Group | Experimental | Drug: SHR3680 Tablet, Drug: SHR2554 Tablet, Drug: Enzalutamide Tablet, Drug: Darotamine Capsule |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093 for InjectionHS-20093 for injection. | Drug | Cohort 1 Group |
| SHR3680 TabletSHR3680 tablet. | Drug | Cohort 1 Group, Cohort 2 Group |
| Abiraterone TabletAbiraterone tablet. | Drug | Cohort 1 Group |
| SHR2554 TabletSHR2554 tablet. | Drug | Cohort 2 Group |
| Enzalutamide TabletEnzalutamide tablet. | Drug | Cohort 2 Group |
| Darotamine CapsuleDarotamine capsule. | Drug | Cohort 2 Group |
Primary outcome
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.
9 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-20093 for Injection, SHR3680 Tablet and Abiraterone Tablet 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 10 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 3 Mar 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 phase mean?
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 Wenliang Wang (+86-0518-82342973, wenliang.wang@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cohort 1: 6-month undetectable Prostate Specific Antigen (PSA) rate. (time frame: 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2026.