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Tests treatment safety and results for Prostate Cancer
Official title A Study to Evaluate the Safety and Drug Levels of ASP5541 in Chinese Participants With Prostate Cancer
ClinicalTrials.gov ID: NCT07339267
What this study is testing
What is ASP5541?
ASP5541 is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for prostate cancer.
Also referred to as PRL-02.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In this study, ASP5541 will be given to Chinese men with prostate cancer. It will be given together with prednisone and androgen deprivation therapy (ADT).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- Participant is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or...
- 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 must have an estimated life expectancy of ≥ 12 months with metastatic hormone-sensitive prostate cancer (mHSPC) or ≥ 6 months with...
- Participant is able to understand and comply with all study requirements and procedures.
- Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance...
You likely can't join if
- Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study...
- Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and/or...
- 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
See the full eligibility criteria
Who can join
- 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 must have an estimated life expectancy of ≥ 12 months with metastatic hormone-sensitive prostate cancer (mHSPC) or ≥ 6 months with metastatic castration-resistant prostate cancer (mCRPC).
- Participant is able to understand and comply with all study requirements and procedures.
- Participant has been diagnosed with mCRPC or mHSPC documented by metastatic lesions on a bone scan, computed tomography (CT), magnetic resonance imaging (MRI) or prostate-specific membrane antigen positron emission...
- Participant is receiving ongoing androgen deprivation therapy (ADT) with a gonadotropin-releasing hormone (GnRH) analogue or has a history of bilateral orchiectomy (i.e., surgical or medical castration). Participant...
- If the participant has mCRPC, participant has evidence of disease progression defined as 1 or more of the following criteria at study entry:
- Evidence of radiographic progression of disease prior to first dose and following the most recent prostate cancer treatment, defined as progressive disease on CT/MRI per Response Evaluation Criteria in Solid Tumours...
- PSA progression defined as an increase in PSA of at least 25% and ≥ 1 ng/mL above the nadir, confirmed by a second value 1 week later, and with at least 1 of the measurements within 90 days prior to screening. PSA nadir...
- If the participant has mCRPC, participant has a serum testosterone level \< 1.73 nmol/L (\< 50 ng/dL) at the Screening visit.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 7 months after final ASP5541 administration.
- Male participant 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 administration.
- Male participant must not donate sperm during the treatment period and for 7 months after final ASP5541 administration.
- Participant has adequate ventrogluteal muscle mass for an intramuscular injection.
- Participant agrees not to participate in another treatment study while receiving ASP5541 in the present study.
What rules you out
- Participant has any concurrent disease, infection or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the...
- Participant has known active central nervous system (CNS) metastases. Note: Participant with CNS metastases who has been treated with surgery and/or radiation therapy, who is off pharmacologic doses of glucocorticoids...
- 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
- Participant has clinically significant cardiac disease, defined as any of the following:
- Clinically significant cardiac arrhythmias including bradyarrhythmia which are poorly controlled. Rate-controlled atrial fibrillation is permitted.
- Congenital long QT syndrome.
- QT interval corrected by Fridericia's formula (QTcF) ≥450 msec at Screening. If the QT interval corrected for heart rate intervals (QTc) is prolonged in a participant with a pacemaker or bundle branch block, the...
- History of clinically significant cardiac disease or congestive heart failure greater than New York Heart Association (NYHA) Class II or left ventricular ejection fraction measurement of \< 50% at baseline. Participant...
- Uncontrolled hypertension, defined as systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg that has been confirmed by 2 successive measurements despite optimal medical management.
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 3 months before start of study medication...
- 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: Participant receiving ongoing hormone...
- 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...
- Participant has/had febrile illness or symptomatic, viral, bacterial (including upper respiratory infection) or fungal (noncutaneous) infection within 28 days prior to day 1.
- Participant received a blood transfusion within 1 month of the first dose of study intervention.
- Participant has a history of impaired pituitary or adrenal gland function (e.g., Addison's disease, Cushing's syndrome).
- Participant has hemoglobin A1c (HbA1c) \> 10% (if diabetes mellitus was previously diagnosed) or HbA1c \> 8% (if diabetes mellitus was previously undiagnosed). (Excluded participant may be rescreened after referral and...
- 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 (hepatitis B...
- Participant has moderate or severe hepatic impairment (Child-Pugh Class B or C).
- Participant has a known history of human immunodeficiency virus (HIV) infection (HIV antibody positive).
- Participant has a body mass index \> 40 kg/m2.
- Participant has a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition criteria within 2 years before screening.
- Participant received treatment with glucocorticoids greater than the equivalent of 10 mg per day of prednisone within 4 weeks prior to C1D1. The use of topical, intraocular, inhalational, intranasal or intra-articular...
- Participant received treatment with Chinese traditional medications with known antitumor activity or herbal products within 4 weeks prior to C1D1 (e.g., saw palmetto). Participant must agree not to use such Chinese...
- Participant is receiving current treatment with systemic ketoconazole, abiraterone acetate (AA) or any other cytochrome P450 17A1 (CYP17) inhibitor. Participant who has received systemic ketoconazole, AA or any other...
- Participant received prior systemic treatment with a strong inducer or inhibitor of cytochrome p450 3A4 (CYP3A4) within 4 weeks of first dose of study intervention. Concomitant use of strong inducers or inhibitors of...
- Participant requires use of biotin (i.e., vitamin B7) or supplements containing biotin higher than the daily adequate intake of 30 μg. Note: Participant who switches from a high dose to a dose of 30 μg/day or less prior...
- Participant is required to use any prohibited medication on the List of Excluded Concomitant Medications.
- For mCRPC participants only: Participant has been treated with any of the following for prostate cancer, during the indicated time frame prior to enrollment:
- Hormonal therapy (e.g., androgen receptor blockers [AR] antagonists, second-generation androgen receptor pathway inhibitors [including enzalutamide, apalutamide, darolutamide, rezvilutamide and AA], 5-alpha reductase...
- Chemotherapy within 2 weeks or 5 half-lives of C1D1 (whichever is longer)
- Biologic therapy within 4 weeks of C1D1
- Immunotherapy within 4 weeks of C1D1
- Radiation therapy (includes radioligands) within 4 weeks of C1D1
- For mHSPC participants only: Participant has received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer (the following exceptions are permitted):
- Up to 4 months of ADT with GnRH agonists or antagonists or orchiectomy (within 3 months prior to C1D1) with or without concurrent antiandrogens.
- Participant may have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to C1D1.
- Up to 6 cycles of docetaxel therapy, with the last dose of docetaxel ≤ 2 months prior to C1D1. A participant who has received docetaxel should have maintained a response to docetaxel of stable disease or better, by...
- Up to 6 months of ADT with GnRH agonists or antagonists or orchiectomy with or without concurrent antiandrogens prior to C1D1 if subject was treated with docetaxel, with no radiographic evidence of disease progression...
- Participant has received any investigational therapy within 4 weeks or 5 half-lives (whichever is longer) prior to C1D1.
- Participant has received ASP5541 previously.
- Participant has absolute neutrophil count \< 1500/μL, platelet count \< 100000/μL or hemoglobin \< 9 g/dL (6.2 mmol/L) or international normalized ratio (INR) ≥ 1.5 (unless participant is taking oral anticoagulants in...
- Participant has serum total bilirubin \> 1.5 x upper limit of normal (ULN) (except participants with documented Gilbert's disease), or serum alanine aminotransferase or aspartate aminotransferase \> 2.5 x ULN at...
- Participant does not have adequate renal function defined as a calculated creatinine clearance \< 30 mL/min as determined by a validated algorithm for calculating creatinine clearance.
- Participant has serum albumin \< 3.0 g/dL (30 g/L) at Screening.
- Participant has a known or suspected hypersensitivity to ASP5541, prednisone, or any components of the formulations used.
- Participant has a gastrointestinal disorder affecting absorption.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.