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Prostate Cancer Metastatic DiseasePhase 2NCT06738745

Study of HRS-2189 Combined HRS-5041 in Prostate Cancer

A Phase 2 study testing HRS-2189 and HRS-5041 in people with Prostate Cancer Metastatic Disease, run by Fudan University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic prostate cancer. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
Conditions the study is for
Prostate Cancer Metastatic Disease
What is being tested?
HRS-2189 and HRS-5041
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
31 Dec 2024to 31 Aug 2027
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

  • 18 years to 80 years old (including boundary values), male subjects;
  • ECOG PS Score: 0~1;
  • Histologically or cytologically confirmed prostate adenocarcinoma, and no prior diagnosed as neuroendocrine carcinoma or small cell carcinoma;
  • Disease progression when enrolled in the study;
  • Confirmed metastatic disease by CT/MRI/99mTc radioactive bone scan;
  • Subjects must have a life expectancy ≥ 3 months;
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  • Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
  • Male subjects who have partner of childbearing potential should agree to take action of contraception and avoid to donate sperm;
  • Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.

Who cannot join

  • Known existence of CNS metastasis or meningeal metastasis, or known history of primary CNS tumor;
  • Severe bone injury caused by bone metastasis identified by investigators, including uncontrolled severe bone pain, pathological bone fracture at the important part and spinal cord compression having occurred for the last 6 months or expected to occur in the near future;
  • Existence of third space fluid that is not well controlled by effective methods, e.g. drainage;
  • Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy, immunological therapy or attenuated live vaccine within 4 weeks before first dose of study therapy (6-week washout period for bicalutamide);
  • Has been enrolled in other clinical trials within 4 weeks before first dose of study therapy;
  • Use of other antitumor treatment during the study;
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  • Damage caused by any prior anti-tumor treatment has not recovered to ≤ grade 1 or criteria specified by this study (per NCI-CTCAE 5.0; except alopecia or other tolerable adverse events identified by investigators);
  • Uncontrolled hypertension, or prior hypertensive crisis or history of hypertension;
  • Existence of arterial/venous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
  • Existence of one of multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and bowel obstruction), or active gastrointestinal disease or other diseases which may obviously affect distribution of drug absorption, metabolism or excretion;
  • Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
  • Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
  • Subjects with innate or acquired immunodeficiency (such as HIV infection); Known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;
  • Other malignancy within prior 3 years before first dose of study therapy, except curatively treated cancer, including radical therapy-treated skin basal cell carcinoma or skin squamous cell carcinoma, papillary thyroid carcinoma, or any type of in situ carcinoma with complete excision, such as in situ cancer of the cervix, ductal carcinoma in situ of breast;
  • Hypersensitivity to study therapy or any of its excipients;
  • Uncontrolled cardiovascular clinical symptom or disease within 6 months before first dose of study therapy;
  • Other conditions that might influence the study and analysis of results in the opinion of 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.

Dingwei Ye, Chief physician contact

+8621-64175590

dwyeli@163.com

Shanshan Wang, Attending physician contact

China1 site

  • Fudan Cancer Hospital

    Shanghai, Shanghai Municipality, 200230

    Dingwei Ye, Chief physician, +8621-64175590, dwyeli@163.com

    Shanshan Wang, Attending physician

Other trials in China

About this study

Official title: A Phase II Study of HRS-2189 Combined HRS-5041 in Metastatic Prostate Cancer

Our study is aimed to evaluate the efficacy and safety of HRS-2189 combined with HRS-5041 in metastatic prostate cancer.

Being tested
HRS-2189, HRS-5041

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HRS-2189Drug

    HRS-2189

  • HRS-5041Drug

    HRS-5041

Study groups in NCT06738745
Study groupRoleWhat they receive
HRS-2189 + HRS-5041ExperimentalAll subjects enrolled will receive HRS-2189 + HRS-5041 combination therapy.
Receives: Drug: HRS-2189; Drug: HRS-5041

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PSA50

    PSA50 is the percentage of evaluable patients with ≥50% decline in PSA level, measured at baseline and the time point of every 4 weeks in efficacy analysis set.

    Measured: up to 2 years

Secondary outcomes (9)

  1. PSA30

    PSA30 is the percentage of evaluable patients with ≥30% decline in PSA level measured at baseline and the time point of every 4 weeks in efficacy analysis set.

    Measured: up to 2 years

  2. Time to PSA progression

    The definition is the time from the date of first dose until the date of first PSA progression or death (by any cause in the absence of progression). PSA progression is per PCWG3 criteria and newest version of CSCO guideline as follows: 1) if PSA level declines from baseline, PSA level is ≥25% increase from baseline and ≥1 ng/ml, which needs to be confirmed after at least 4 weeks; 2) if PSA level has not declined from baseline, PSA level is ≥25% increase from baseline and ≥1 ng/ml after at least 12 weeks from the date of first dose.

    Measured: up to 2 years

  3. ORR by investigator

    ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1, and measured at baseline and the time point of every 8 weeks in first 16 weeks, at the time point of every 12 weeks after first 16 weeks.

    Measured: up to 2 years

  4. DCR by investigator

    DCR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response), PR (partial response) or SD (stable disease) per RECIST v1.1, and measured at baseline and the time point of every 8 weeks in first 16 weeks, at the time point of every 12 weeks after first 16 weeks.

    Measured: up to 2 years

  5. DoR

    DoR is the time from the date of first detection of objective response (which is subsequently confirmed) until the date of objective radiographic disease progression.

    Measured: up to 2 years

  6. rPFS

    rPFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression) per RECIST v1.1 and PCWG3 criteria.

    Measured: up to 2 years

  7. Time to next skeletal-related event

    The definition is the time from the date of first dose until the date of next skeletal-related event. Skeletal-related events include radiotherapy or surgery to the bone, pathological bone fracture, spinal cord compression, or changing anti-tumor treatment in order to relieve bone pain.

    Measured: up to 2 years

  8. OS

    OS is the time from the date of first dose until the date of death by any cause.

    Measured: up to 2 years

  9. Percentage of participants who experience an adverse event [Safety and Tolerability]

    An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. Percentage of participants who experience an adverse event and discontinue study drug due to an AE.

    Measured: From the time of informed consent provided to 30 days after the last dose of study therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2024
  2. Study start31 Dec 2024 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06738745
Sponsor's protocol ID
CRPC-MUL-IIT-HRS2189-HRS5041
Status last verified
Dec 2024
First submitted
22 Nov 2024
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-2189 and HRS-5041 in people with Prostate Cancer Metastatic Disease, run by Fudan University 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 17 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: opening soon, as of the sponsor's last update on 18 Dec 2024. 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 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 Dingwei Ye, Chief physician (+8621-64175590, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PSA50 (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06738745.

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 18 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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