Treatment for metastatic prostate cancer using HRS-1167 with other medications

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

This study is testing if a new drug called HRS-1167, when taken with other medications, can safely help men with metastatic prostate cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Drugs / interventions: prednisone
• Locations: 2 sites (Hefei, Anhui and 1 other locations)
• Trial ID: NCT06689163 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and pharmacokinetics of HRS-1167 tablets when combined with abiraterone acetate and prednisone in patients with metastatic prostate cancer. It aims to determine the recommended phase 2 dose (RP2D) and assess the effectiveness of this combination therapy. Participants will undergo regular monitoring and assessments to gather data on their response to the treatment. The study is designed for male patients aged 18 and older with confirmed metastatic prostate cancer.

Who should consider this trial

Good fit: Ideal candidates are males over 18 years old with histologically confirmed metastatic adenocarcinoma of the prostate.

Not a fit: Patients who have received systemic antitumor therapy within 4 weeks prior to the study may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with metastatic prostate cancer.

How similar studies have performed: Other studies have shown promise in combining therapies for metastatic prostate cancer, but the specific combination of HRS-1167 with abiraterone and prednisone is novel.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation in this study, signed informed consent, compliance is good, and are willing and able to comply with planned visits.
2. The age is above 18 years old, male.
3. Adenocarcinoma of the prostate confirmed with histologically or cytologically.
4. Metastatic lesions were confirmed by CT/MRI or radionuclide bone scan (99mTc).
5. ECOG score is 0 or 1.
6. An expected survival of ≥ 12 weeks.
7. 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.

Exclusion Criteria:

1. 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.
2. 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.
3. Subjects had cancerous meningitis or untreated central nervous system metastases.
4. 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.
5. 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.
6. 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.
7. 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.
8. Systemic therapy with corticosteroids or other immunosuppressants within 2 weeks prior to the first dose.
9. 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.
10. Have high blood pressure that is not well controlled by antihypertensive medication; A history of hypertensive crisis or hypertensive encephalopathy.
11. Have clinical symptoms or diseases of the heart that are not well controlled.
12. Arterial/venous thrombosis events occurred within 6 months prior to the first dose.
13. Inability to swallow pills normally, or gastrointestinal dysfunction, may affect drug absorption.
14. Subjects who had a severe infection within 1 month prior to the first dose.
15. A known history of human immunodeficiency virus positive; Known to have active hepatitis.
16. The toxicity caused by previous antitumor therapy has not recovered to ≤ grade 1.
17. Live vaccine was administered within 4 weeks prior to the first dose or possibly using during the study.
18. 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.

Where this trial is running

Hefei, Anhui and 1 other locations

• The First Affiliated Hospital Of Anhui Medical University — Hefei, Anhui, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Ke Liu, M.M

Conditions: Prostate Cancer