Clinical trial NCT06738745: Study of HRS-2189 Combined HRS-5041 in Prostate Cancer
Official title: A Phase II Study of HRS-2189 Combined HRS-5041 in Metastatic Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Prostate Cancer Metastatic Disease
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 90
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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;
* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: PSA50
timeFrame: up to 2 years
Secondary outcomes:
measure: PSA30
timeFrame: up to 2 years
measure: Time to PSA progression
timeFrame: up to 2 years
measure: ORR by investigator
timeFrame: up to 2 years
measure: DCR by investigator
timeFrame: up to 2 years
measure: DoR
timeFrame: up to 2 years
measure: rPFS
timeFrame: up to 2 years
measure: Time to next skeletal-related event
timeFrame: up to 2 years
measure: OS
timeFrame: up to 2 years
measure: Percentage of participants who experience an adverse event [Safety and Tolerability]
timeFrame: From the time of informed consent provided to 30 days after the last dose of study therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Dingwei Ye, Chief physician
role: PRINCIPAL_INVESTIGATOR
References: