2024-517653-27-00招募中2 期
A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 89
- 试验地点
- 26
- 主要终点
- • Proportion of ARPI-naïve mCRPC participants with PSA decline ≥ 90% from baseline (Cohort 1)
研究概览
简要总结
• To evaluate the efficacy of ASP5541 with prednisone or prednisolone compared with abiraterone acetate (AA) with prednisone or prednisolone in androgen receptor pathway inhibitor (ARPI)-naïve metastatic castration-resistant prostate cancer (mCRPC) participants (Cohort 1) • To evaluate the safety of ASP5541 without steroids (Cohort 2 safety run-in) in ARPI-naïve metastatic hormone-sensitive prostate cancer (mHSPC) participants • To evaluate the efficacy of ASP5541 without steroids compared with abiraterone acetate (AA) with prednisone or prednisolone in androgen receptor pathway inhibitor-naïve mHSPC participants (Cohort 2) • To evaluate the safety of ASP5541 with prednisone or prednisolone in Japanese mCRPC or mHSPC participants (Cohort 3)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Participant is male and at least 18 years of age or older at time of consent.
- •Participant has been diagnosed with mHSPC documented by metastatic lesions on a bone scan, CT, MRI or PSMA-PET. (Cohort 2)
- •Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, CT, MRI, or PSMA-PET. (Cohort 3)
- •Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.
- •Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or ECOG performance status of 2 if due to bone pain.
- •Participant with mHSPC must have an estimated life expectancy of ≥ 12 months or >6 months if participant has metastatic castration-resistant prostate cancer (mCRPC).
- •Participant is able to understand and comply with all study requirements and procedures, including completion of patient-reported outcome questionnaires, based on the assessment of the investigator.
- •Male participant: ●Must agree to use defined forms of contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration. ●Must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration. ●Must not donate sperm during the treatment period and for 7 months after final ASP5541 or for 3 months after AA study intervention administration.
- •Participant has provided informed consent, which includes compliance with the requirements and restrictions listed in the ICF and protocol
- •Participant agrees not to participate in another interventional study while receiving ASP5541 in the present study.
- •Participant has been diagnosed with mCRPC documented by metastatic lesions on a bone scan, CT, MRI or prostate-specific membrane antigen positron emission tomography (PSMA-PET). (Cohort 1)
排除标准
- •Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the participant to participate in the study, which places the participant at undue risk or complicates the interpretation of data in the opinion of the investigator.
- •Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).
- •Participant has a known history of HIV infection. No HIV testing is required unless mandated by a local health authority.
- •Participant has a body mass index > 40 kg/m
- •Participant has a history of drug or alcohol abuse according to DSM-5 criteria within 2 years before screening.
- •For Cohort 1: Prior treatment with a second-generation ARPI (e.g., AA, enzalutamide, apalutamide or darolutamide). NOTE: limited treatment with a second-generation ARPI in the neo-adjuvant, adjuvant or non-metastatic biochemically recurrent setting is permitted as long as there was no evidence of disease progression for at least 6 months following last dose.
- •Participant has clinically significant cardiac disease.
- •For Cohort 2: Prior treatment with a second-generation ARPI (e.g., AA, enzalutamide, apalutamide or darolutamide). Note: limited treatment with a second-generation ARPI in the neo-adjuvant, adjuvant or non-metastatic biochemically recurrent setting is permitted as long as there was no evidence of disease progression for at least 6 months following last dos
- •Participant has a known additional malignancy beyond prostate cancer that requires active treatment, with the exception of any of the following: ● Adequately treated basal cell carcinoma, squamous cell carcinoma of the skin or in situ carcinoma of any type ● Adequately treated Stage I cancer from which the participant is currently in remission and has been in remission for ≥ 2 years ● Any other cancer from which the participant has been disease-free for ≥ 5 years The medical monitor should be contacted for any questions regarding this exclusion criterion.
- •Participant has any unresolved National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) (version 5.0) Grade > 2 toxicity at the Screening visit. NOTE: A participant receiving ongoing hormone replacement therapy for endocrine immune-related AEs without clinical symptoms will not be excluded.
- •Participant has had major surgery (e.g., requiring general anesthesia) within 90 days before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to participate in the study.
- •Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to Cycle 1 Day
- •Participant received a blood transfusion within 1 month of Cycle 1 Day
- •Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
- •Participant has HbA1c > 10% and was previously diagnosed with diabetes mellitus. Participant has HbA1c > 8% and was not previously diagnosed with diabetes mellitus (excluded participants may be rescreened after referral and evidence of improved control of their condition).
- •Participant has jaundice or known current active liver disease from any cause, including hepatitis A (hepatitis A virus IgM positive, but testing for hepatitis A in screening is not required), hepatitis B [HBsAg positive, or HBV DNA positive if HBsAg negative/anti-HBc positive]), or hepatitis C (HCV antibody positive, confirmed by HCV RNA).
结局指标
主要结局
• Proportion of ARPI-naïve mCRPC participants with PSA decline ≥ 90% from baseline (Cohort 1)
• Proportion of ARPI-naïve mCRPC participants with PSA decline ≥ 90% from baseline (Cohort 1)
• Rates of no mineralocorticoid toxicity, defined as experiencing neither Grade ≥ 1 hypokalemia nor Grade ≥ 2 hypertension (Cohort 2 safety-run in)
• Rates of no mineralocorticoid toxicity, defined as experiencing neither Grade ≥ 1 hypokalemia nor Grade ≥ 2 hypertension (Cohort 2 safety-run in)
• Proportion of mHSPC participants with PSA ≤ 0.2 ng/mL at 8 months (Cohort 2)
• Proportion of mHSPC participants with PSA ≤ 0.2 ng/mL at 8 months (Cohort 2)
• dose-limiting toxicities (DLTs), AEs, serious Adverse Events (SAEs), laboratory results (including chemistry, hematology and urinalysis), electrocardiograms (ECGs), vital signs, physical examinations and ECOG performance status scores (Cohort 3)
• dose-limiting toxicities (DLTs), AEs, serious Adverse Events (SAEs), laboratory results (including chemistry, hematology and urinalysis), electrocardiograms (ECGs), vital signs, physical examinations and ECOG performance status scores (Cohort 3)
次要结局
- • Radiographic progression-free survival (rPFS), defined as the time from date of randomization/first dose date until the date of radiological progressive disease (PD) per RECIST v1.1 and PCWG3 as determined by investigator or death from any cause • Prostate-specific antigen (PSA) decline ≥ 50% from baseline • PSA decline ≥ 90% from baseline (Cohorts 2 and 3 only)
- • Testosterone suppression to ≤ 1 ng/dL, or achieves a ≥ 90% reduction from baseline level • Mean testosterone values by time point
- • PSA undetectable rate (≤ 0.2 ng/mL) (Cohorts 1 and 3 only) • PSA undetectable rate (≤ 0.02 ng/mL) • Time to PSA progression per PCWG3 criteria • Objective response rate per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease • Duration of response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
- • Best overall response per RECIST v1.1 for soft tissue disease and PCWG3 for bone disease
- • AEs, SAEs, laboratory results (including chemistry, hematology, urinalysis • spot urine potassium and creatinine (Cohort 2 only) • ECGs, vital signs, physical examinations and ECOG performance status scores (Cohorts 1 + 2 only)
- Time to pain progression defined using pain scores from the BPI-SF and opiate analgesic use.
研究者
Head of Clinical Trial Unit Regulatory Affairs
Scientific
Astellas Pharma Global Development Inc.
研究点 (26)
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