Prostate CancerPhase 1NCT06783829
A Study of SHR-4394 Injection in Subjects With Prostate Cancer
A Phase 1 study testing SHR4394 in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer. 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?
- SHR4394
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 22 Jan 2025to Mar 2027
- Phase
- Phase 1
- 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
- Age range: 18-85 years old, male;
- ECOG score for physical condition is 0-1 points;
- Expected survival period ≥ 6 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination;
- Patients with at least one metastasis lesion;
- Disease progression on or after the most-recent prior regimen;
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- Continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) or previous bilateral orchidectomy;
- Testosterone was at castration level;
- Adequate organ function.
Who cannot join
- Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
- Unresolved to CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy;
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Uncontrollable tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
- Other serious concomitant disease;
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- Previous or co-existing malignancies;
- History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-4394;
- Active hepatitis B or active hepatitis C;
- Other inappropriate situation considered by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Qiang Wei, 18980601425, wq933@hotmail.com
Qiang Wei
About this study
Official title: A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- SHR4394
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR4394Drug
SHR4394
| Study group | Role | What they receive |
|---|---|---|
| SHR4394 | Experimental | Not described Receives: Drug: SHR4394 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: 3 weeks.
Maximal tolerable dose (MTD)
Measured: 3 weeks.
Adverse events (AEs)
Measured: Screening up to study completion, an average of 1 year.
Recommended phase II dose (RP2D)
Measured: Screening up to study completion, an average of 1 year.
Secondary outcomes (4)
Objective response rate (ORR)
Measured: Up to approximately 2 years.
Duration of response (DOR)
Measured: Up to approximately 2 years.
Disease control rate (DCR)
Measured: Up to approximately 2 years.
overall survival (OS)
Measured: Up to approximately 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start22 Jan 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT06783829
- Sponsor's protocol ID
- SHR-4394-101
- Status last verified
- Feb 2025
- First submitted
- 14 Jan 2025
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-4394 Injection in Subjects With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06783829
- Acronym / sponsor ID
- SHR-4394-101
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 20 Jan 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 an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-4394 injection in subjects with prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR4394 | Experimental | Drug: SHR4394 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age range: 18-85 years old, male;
- ECOG score for physical condition is 0-1 points;
- Expected survival period ≥ 6 months;
- Prostate adenocarcinoma confirmed by histological or cytological examination;
- Patients with at least one metastasis lesion;
Key exclusion criteria (10 listed)
- Received systemic anticancer treatments or clinical investigational drugs 4 weeks prior to the initiation of the study treatment;
- Unresolved to CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy;
- Meningeal metastasis history or clinical symptoms of central nervous system metastasis;
- Uncontrollable tumor-related pain;
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms;
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 |
|---|---|---|
| SHR4394SHR4394 | Drug | SHR4394 |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 3 weeks.
Maximal tolerable dose (MTD)
Time frame: 3 weeks.
Adverse events (AEs)
Time frame: Screening up to study completion, an average of 1 year.
Recommended phase II dose (RP2D)
Time frame: Screening up to study completion, an average of 1 year.
4 secondary outcomes
Objective response rate (ORR)
Time frame: Up to approximately 2 years.
Duration of response (DOR)
Time frame: Up to approximately 2 years.
Disease control rate (DCR)
Time frame: Up to approximately 2 years.
overall survival (OS)
Time frame: Up to approximately 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 27 Feb 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SHR4394 in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 9 inclusion and 10 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 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 Qi Shi (0518-82342973, qi.Shi.qs16@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 3 weeks.). 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 27 Feb 2025.