Clinical trial NCT05942001: Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Prostate Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 100
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
Intervention model description: HRS-5041 single arm
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, tolerability and preliminary efficacy of HRS-5041 in men with progressive metastatic castration resistant prostate cancer. The objective of this study was to determine the dose-limiting toxicity, maximum tolerance and recommended dose of HRS-5041 in phase II study.


Eligibility criteria: Inclusion Criteria:

1. Able and willing to provide a written informed consent.
2. Age 18-80 years old, gender unlimited.
3. The physical status score of the Eastern Tumor Cooperative Group (ECOG) was 0 \~ 1.
4. Predicted survival ≥12 weeks.
5. Histological or cytological confirmed adenocarcinoma of the prostate.
6. Patients progressed on taxane chemotherapy and at least one prior secondary hormonal therapy.

Exclusion Criteria:

1. Prior treatment with an androgen receptor (AR) degrader.
2. Plan to receive any other antitumor therapy during this trial.
3. Receiving other investigational drugs or treatments that are not on the market within 4 weeks prior to the initial administration of the study.
4. Patients with known brain metastases.
5. Any significant medical condition, such as uncontrolled infection, laboratory abnormality, or psychiatric illness.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: Up to 28 days
measure: Maximum tolerated dose (MTD)
timeFrame: Up to 28 days
measure: Recommended Phase 2 Dose (RP2D) of HRS-5041
timeFrame: Up to 28 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs) evaluated using the NCI CTCAE v5.0 criteria
timeFrame: From the time of consent at screening until 30 days after the subject discontinues study treatment, up to 2 years
measure: Pharmacokinetics - Area under the plasma concentration time curve (AUC)
timeFrame: 12 weeks
measure: Pharmacokinetics - Maximum plasma concentration (Cmax)
timeFrame: 12 weeks
measure: Pharmacokinetics - Time to Cmax (Tmax)
timeFrame: 12 weeks
measure: Prostate Specific Antigen (PSA) decline of ≥ 50% from baseline (PSA50)
timeFrame: 24 months
measure: PSA Progression Free Survival (PFS)
timeFrame: 24 months
measure: Objective soft tissue response defined by complete response (CR) or partial response (PR) per Prostate Cancer Clinical Trials Working Group 3 (PCWG3)
timeFrame: 24 months
measure: Radiographic progression free survival (rPFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine, Renji Hospital
state: Shanghai
Study officials:
References: