Advanced Prostate CancerPhase 1/2NCT06006104
Phase 1/2 Clinical Study of HRS-4357 in Patients With Advanced Prostate Cancer
A Phase 1/2 study testing HRS-4357 injection in people with Advanced Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
Trial summary
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- HRS-4357 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 31 Oct 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
- Male, age ≥18 years;
- ECOG score 0 - 1;
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate;
Who cannot join
- Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
- Active syphilis infection.
- Known hypersensitivity to components of the study drug or its analogues.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced prostate cancer.
- Conditions
- Advanced Prostate Cancer
- Being tested
- HRS-4357 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4357 injectionDrug
HRS-4357 injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-4357 injection | Experimental | Not described Receives: Drug: HRS-4357 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prog Dose limiting toxicity (DLT)
Measured: up to 9 months follow-up
recommended phase 2 dose (RP2D)
Measured: up to 9 months follow-up
recommended dosing cycle.
Measured: up to 9 months follow-up
PSA50 response rate
Measured: up to 12 weeks follow-up
Secondary outcomes (16)
Maximum plasma concentration (Cmax)
Measured: up to 6 weeks follow-up
time to maximum plasma concentration (Tmax)
Measured: up to 6 weeks follow-up
area under the plasma concentration-time curve (AUC)
Measured: up to 6 weeks follow-up
clearance (Cl)
Measured: up to 6 weeks follow-up
volume of distribution (Vz)
Measured: up to 6 weeks follow-up
terminal half-life (t1/2)
Measured: up to 6 weeks follow-up
cumulative urinary excretion of radioactive dose
Measured: up to 6 weeks follow-up
Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
Measured: up to 6 weeks follow-up
PSA90 response rate
Measured: up to 12 weeks follow-up]
time to PSA progression
Measured: up to 9 months follow-up
Overall Response Rate (ORR)
Measured: up to 20 months follow-up
Disease control Rate (DCR)
Measured: up to 20 months follow-up
Duration of Response (DoR)
Measured: up to 20 months follow-up
Radiographic Progression-free Survival (rPFS)
Measured: up to 9 months follow-up
Overall Survival (OS)
Measured: up to 20 months follow-up
Incidence and severity of AEs and SAEs
Measured: up to 20 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start30 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 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
- NCT06006104
- Sponsor's protocol ID
- HRS-4357-101
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2023
- Last updated
- 23 Aug 2023
- 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 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Pharmacokinetics, Radiation Dosimetry, Safety and Preliminary Efficacy of HRS-4357 in Patients With PSMA Positive Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT06006104
- Acronym / sponsor ID
- HRS-4357-101
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 23 Aug 2023 (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.
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry, and preliminary efficacy of HRS-4357 injection in adult patients with advanced 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 |
|---|---|---|
| HRS-4357 injection | Experimental | Drug: HRS-4357 injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing;
- Male, age ≥18 years;
- ECOG score 0 - 1;
- Histologically and/or cytologically confirmed adenocarcinoma of the prostate;
Key exclusion criteria (4 listed)
- Spinal cord compression with clinical symptoms, or clinical symptoms and/or imaging findings suggesting imminent spinal cord compression.
- Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study.
- Active syphilis infection.
- Known hypersensitivity to components of the study drug or its analogues.
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 |
|---|---|---|
| HRS-4357 injectionHRS-4357 injection | Drug | HRS-4357 injection |
Primary outcome
Prog Dose limiting toxicity (DLT)
Time frame: up to 9 months follow-up
recommended phase 2 dose (RP2D)
Time frame: up to 9 months follow-up
recommended dosing cycle.
Time frame: up to 9 months follow-up
PSA50 response rate
Time frame: up to 12 weeks follow-up
16 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to 6 weeks follow-up
time to maximum plasma concentration (Tmax)
Time frame: up to 6 weeks follow-up
area under the plasma concentration-time curve (AUC)
Time frame: up to 6 weeks follow-up
clearance (Cl)
Time frame: up to 6 weeks follow-up
volume of distribution (Vz)
Time frame: up to 6 weeks follow-up
terminal half-life (t1/2)
Time frame: up to 6 weeks follow-up
cumulative urinary excretion of radioactive dose
Time frame: up to 6 weeks follow-up
Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs;
Time frame: up to 6 weeks follow-up
PSA90 response rate
Time frame: up to 12 weeks follow-up]
time to PSA progression
Time frame: up to 9 months follow-up
Overall Response Rate (ORR)
Time frame: up to 20 months follow-up
Disease control Rate (DCR)
Time frame: up to 20 months follow-up
Duration of Response (DoR)
Time frame: up to 20 months follow-up
Radiographic Progression-free Survival (rPFS)
Time frame: up to 9 months follow-up
Overall Survival (OS)
Time frame: up to 20 months follow-up
Incidence and severity of AEs and SAEs
Time frame: up to 20 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRS-4357 injection in people with Advanced Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd..
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueying Zheng (+0518-82342973, xueying.zheng.xz17@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prog Dose limiting toxicity (DLT) (time frame: up to 9 months follow-up). 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 23 Aug 2023.