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Prostate CancerPhase 1/2NCT06689163

A Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone

A Phase 1/2 study testing HRS-1167 tablets, Abiraterone Acetate tablets（II） and Prednisone Acetate tablets in people with Prostate Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
HRS-1167 tablets, Abiraterone Acetate tablets（II） and Prednisone Acetate tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
2 sitesChina
Study dates
11 Dec 2024to 31 Dec 2026
Phase
Phase 1/2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this study, signed informed consent, compliance is good, and are willing and able to comply with planned visits.
  • The age is above 18 years old, male.
  • Adenocarcinoma of the prostate confirmed with histologically or cytologically.
  • Metastatic lesions were confirmed by CT/MRI or radionuclide bone scan (99mTc).
  • ECOG score is 0 or 1.
  • An expected survival of ≥ 12 weeks.
  • Male subjects whose partner is women of childbearing potential (WOCBP) are required to use highly effective contraception from the date of signing the informed consent until 120 days after the last dose of the investigational drug.

Who cannot join

  • Received systemic antitumor therapy 4 weeks before starting study treatment; Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter; Patients who had previously received anti-tumor proprietary Chinese medicine could be enrolled if the interval between the end of treatment and the first study was not less than 2 weeks.
  • Subjects had prior or co-existing malignancies , except for cured basal cell carcinoma of the skin, papillary carcinoma of the thyroid, and other malignancies that had been adequately treated and cured for ≥ 3 years prior to the first dose with evidence of no recurrence or metastasis.
  • Subjects had cancerous meningitis or untreated central nervous system metastases.
  • Imaging showed that the tumor invaded large blood vessels or had unclear boundary with blood vessels. Or patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels during treatment and causing fatal bleeding.
  • Patients with clinical symptoms of cancerous ascites and pleural effusion requiring puncture and drainage; Or received ascites, pleural effusion drainage within 14 days before the first dose.
  • Severe bone injury due to tumor bone metastasis, including poorly controlled severe bone pain, pathological bone fractures and spinal cord compression that occurred within the last 6 months or are likely to occur in the near future.
Show all 18Show fewer
  • Pneumonia with past or current interstitial pneumonia/interstitial lung disease requiring treatment with the glucocorticoid system; Patients with active pneumonia or severe impairment of lung function confirmed by pulmonary function examination.
  • Systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to the first dose.
  • Those with active pulmonary tuberculosis; Patients who had been adequately treated and had stopped anti-tuberculosis therapy for ≥3 months before the first dose could be enrolled.
  • Have high blood pressure that is not well controlled by antihypertensive medication; A history of hypertensive crisis or hypertensive encephalopathy.
  • Have clinical symptoms or diseases of the heart that are not well controlled.
  • Arterial/venous thrombosis events occurred within 6 months prior to the first dose.
  • Inability to swallow pills normally, or gastrointestinal dysfunction, may affect drug absorption.
  • Subjects who had a severe infection within 1 month prior to the first dose.
  • A known history of human immunodeficiency virus positive; Known to have active hepatitis.
  • The toxicity caused by previous antitumor therapy has not recovered to ≤ grade 1.
  • Live vaccine was administered within 4 weeks prior to the first dose or possibly using during the study.
  • In the judgment of the investigator, there are other factors that may affect the results of the study or cause the study to be terminated.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Ke Liu, M.M contact

0518-81220121

ke.liu.kl53@hengrui.com

China2 sites, 2 recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000

    Shusuan Jiang, 0731-88651900, jiangshusuan@hnca.org.cn

    Shusuan Jiang

    Recruiting

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230000

    Chaozhao Liang, 0551-62922800, liang_chaozhao@163.com

    Chaozhao Liang

    Recruiting

Other trials in China

About this study

Official title: An Open, Multicenter Phase Ib/II Study for the Treatment of Metastatic Prostate Cancer With HRS-1167 Tablets Combined With Abiraterone Acetate Tablets and Prednisone

The purpose of this study was to observe and evaluate the tolerability, safety, and pharmacokinetics of HRS-1167 combined with abiraterone acetate tablets (II) and prednisone in patients with metastatic prostate cancer, determine the RP2D, and evaluate the effectiveness.

Conditions
Prostate Cancer
Being tested
HRS-1167 tablets, Abiraterone Acetate tablets（II）, Prednisone Acetate tablets
Medical subject headings
Prostatic Neoplasms

What participants receive

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

  • HRS-1167 tabletsDrug

    HRS-1167 tablets

  • Abiraterone Acetate tablets（II）Drug

    Abiraterone Acetate tablets（II）

  • Prednisone Acetate tabletsDrug

    Prednisone Acetate tablets

Study groups in NCT06689163
Study groupRoleWhat they receive
HRS-1167 combined with abiraterone acetate tablets (II) and prednisoneExperimentalNot described
Receives: Drug: HRS-1167 tablets; Drug: Abiraterone Acetate tablets（II）; Drug: Prednisone Acetate tablets

What is being measured

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

  1. Dose limiting toxicity (DLT)

    Measured: 28 days

  2. Recommended phase II dose (RP2D)

    Measured: 28 days

  3. The dose suspension rate caused by drug-related adverse events

    Measured: 2 years

  4. The dose downregulation rate caused by drug-related adverse events

    Measured: 2 years

  5. The dose termination rate caused by drug-related adverse events

    Measured: 2 years

Secondary outcomes (15)

  1. PSA response rate

    Measured: 1 year

  2. Time to PSA progression as assessed by the investigator

    Measured: 1 year

  3. Objective response rate (ORR)

    Measured: 1 year

  4. Disease control rate (DCR)

    Measured: 1 year

  5. Duration of response (DoR)

    Measured: 1 year

  6. Time to remission (TTR)

    Measured: 1 year

  7. Radiographic progression-free survival (rPFS)

    Measured: 1 year

  8. Overall survival (OS)

    Measured: 3 years

  9. Steady-state peak concentration (Cmax,ss) of HRS-1167

    Measured: 16 weeks

  10. Adverse events

    Measured: 2 years

  11. 12-lead electrocardiogram

    Measured: 2 years

  12. ECOG score

    Measured: 2 years

  13. Steady-state peak time (Tmax,ss) of HRS-1167

    Measured: 16 weeks

  14. Steady-state valley concentration (Cmin,ss)

    Measured: 16 weeks

  15. Steady-state area under the concentration-time curve (AUCss)

    Measured: 16 weeks

Timeline

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

  1. First posted14 Nov 2024
  2. Study start11 Dec 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2026 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06689163
Sponsor's protocol ID
HRS-1167-201-A
Status last verified
Nov 2024
First submitted
12 Nov 2024
Last updated
3 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HRS-1167 tablets, Abiraterone Acetate tablets（II） and Prednisone Acetate tablets 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 7 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 Sep 2025. 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 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?

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 Ke Liu, M.M (0518-81220121, ke.liu.kl53@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: 28 days). The study lists 5 primary outcomes in all. 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 NCT06689163.

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 Sep 2025.

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