JPRN-jRCT2031200384招募中1 期
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 509 in Subjects With Metastatic Castration-Resistant Prostate Cancer
ocal Contact0 个研究点目标入组 441 人开始时间: 2021年3月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 441
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Parts 1, 2, and 5: Participants with histologically or cytologically confirmed metastatic castration-resistant prostate cancer (mCRPC) who are refractory to a novel antiandrogen therapy (abiraterone acetate and/or enzalutamide, apalutamide, or darolutamide) and have failed at least 1 (but not more than 2) taxane regimens including for metastatic hormone-sensitive prostate cancer (mHSPC) (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen).
- •Note: A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. Any NHT that has been administered and has been stopped for reasons other than progression will not be counted as an additional line of treatment .
- •1. Dose exploration phase: Novel antiandrogen therapy must have been given for treatment of metastatic disease.
- •2. Dose expansion phase: participants must not have had more than 2 NHTs and 2 taxane regimens in any setting, and an additional up to 2 other systemic anti-cancer treatments are allowed (eg, anti-PD1, PARP inhibitors, radioligand therapies, sipuleucel-T, experimental agents) Note: Combinations are considered one systemic anti-cancer treatment.
- •- Parts 4A and 4B:
- •1. Participants with histologically or cytologically confirmed mCRPC who have received no or 1 prior NHT (given in any disease setting), and no or 1 taxane (given for hormone sensitive prostate cancer).
- •2. 4A: Participants planning to receive abiraterone acetate for the first time (participants who received prior abiraterone acetate are not eligible).
- •3. 4B: Participants planning to receive enzalutamide for the first time (participants who received prior enzalutamide/apalutamide or daralutamide are not eligible).
- •- All parts:
- •- Participants must have undergone bilateral orchiectomy or be on continuous androgen-deprivation therapy with a gonadotropin releasing hormone (GnRH) agonis tor antagonist.
- •- Total serum testosterone <= 50 ng/dL or 1.7 nmol/L.
- •- Evidence of progressive disease, defined as 1 or more Prostate Cancer Working Group 3 (PCWG3) criteria:
- •1. PSA level >= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
- •2. nodal or visceral progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with PCGW3 modifications.
- •3. appearance of 2 or more new lesions in bone scan.
- •- Eastern Cooperative Oncology Group performance status of 0-1.
- •- Adequate organ function, defined as follows:
- •1. Hematological function:
- •a. absolute neutrophil count >= 1 x 10^9/L (without growth factor support within 7 days from screening assessment).
- •b. platelet count >= 75 x 10^9/L (without platelet transfusion within 7 days from screening assessment).
- •c. hemoglobin >= 9 g/dL (90 g/L) (without blood transfusion within 7 days from screening assessment).
- •2. Renal function:
- •1. estimated glomerular filtration rate based on Modification of Diet in Renal Disease calculation >= 30 ml/min/1.73 m^2.
- •3. Hepatic function:
- •a. aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3 x upper limit of normal (ULN) (or < 5 x ULN for participants with liver involvement).
- •b. total bilirubin (TBL) < 1.5 x ULN (or < 2 x ULN for participants with liver metastases).
- •4. Cardiac function:
- •a. left ventricular ejection fraction > 50% (2-D transthoracic echocardiogram [ECHO] is the preferred method of evaluation; multi-gated acquisition scan is acceptable if ECHO is not availa
排除标准
- •- Pathological finding consistent with pure small cell, neuroendocrine carcinoma of the prostate or any other histology different from adenocarcinoma
- •- Radiation therapy within 4 weeks of first dose (or local or focal radiotherapy within 2 weeks of first dose)
- •- Untreated central nervous system (CNS) metastases or leptomeningeal disease. Participants with a history of treated CNS metastases are eligible if there is radiographic evidence of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study.
- •- Participants with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of investigational product administration.
- •- Confirmed history or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy
- •- Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of dosing
- •NOTE: Simple urinary tract infections and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with sponsor. Screening for chronic infectious conditions is not required.
- •- Positive test for human immunodeficiency virus (HIV)
- •- Exclusion of hepatitis infection based on the following results and/or criteria:
- •- Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
- •- Negative HBsAg and positive for hepatitis B core antibody: Hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
- •- Positive Hepatitis C virus antibody (HCVAb): hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA
- •suggests chronic hepatitis C.
- •- History of arterial or venous thrombosis (eg, stroke, transient ischemic attack, pulmonary embolism, or deep vein thrombosis); for arterial thrombosis within 12 months of AMG 509 initiation; for venous thrombosis, 6 months and stable on anti-coagulation.
- •- Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of AMG 509 with the exception of ischemia or non-ST segment elevation myocardial infarction controlled with stent placement and confirmed by a cardiologist more than 6 months prior to first dose of AMG 509.
- •- Unresolved toxicities from prior anti-tumor therapy not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 1, with the exception of alopecia or toxicities that are stable and well-controlled AND there is agreement to allow by both the investigator and sponsor
- •- History of other malignancy within the past 2 years, with the following exception(s):
- •- malignancy treated with curative intent and with no known active disease present for greater than or equal to 1 years before enrollment and felt to be at low risk for recurrence by the treating physician
- •- adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •- adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ
- •- History or evidence of inflammatory bowel disease (ulcerative colitis or Crohn disease) or any other gastrointestinal disorder causing chronic nausea, vomitin
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