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

NCT06738745 | Not Yet Recruiting Phase 2

• 1 other identifier: CRPC-MUL-IIT-HRS2189-HRS5041
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer Metastatic Disease

Outcome Measures

Primary Outcomes (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.

  up to 2 years

Secondary Outcomes (9)

• PSA30

  up to 2 years

• Time to PSA progression

  up to 2 years

• ORR by investigator

  up to 2 years

• DCR by investigator

  up to 2 years

• DoR

  up to 2 years

Study Arms (1)

HRS-2189 + HRS-5041

EXPERIMENTAL

All subjects enrolled will receive HRS-2189 + HRS-5041 combination therapy.

Drug: HRS-2189; Drug: HRS-5041

Interventions

HRS-2189 DRUG

HRS-2189

HRS-2189 + HRS-5041

HRS-5041 DRUG

HRS-5041

HRS-2189 + HRS-5041

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan Cancer Hospital

Shanghai, Shanghai Municipality, 200230, China

Location

Study Officials

• Dingwei Ye, Chief physician

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dingwei Ye, Chief physician

CONTACT

+8621-64175590; dwyeli@163.com

Shanshan Wang, Attending physician

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 18, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)