EUCTR2019-000998-23-ES进行中（未招募）1 期
A Phase I/II, open label, non-randomized study to evaluate safety, tolerability, pharmacokinetics and clinical activity of S64315 in patients with locally advanced or metastatic breast cancer in combination with various standard treatments including hormonal and cytotoxic agents
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
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研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In Arm 1: S64315 + paclitaxel
- •-Histologically confirmed locally advanced or metastatic TNBC or HR+/Her2- (HR+ (Estrogen or Progesterone) > 10% and Her2- (score 0 or 1 by immunochemistry), FISH BC (Fluorescence In Situ Hybridization) negative if IHC (immuno-histochemistry) score 2):
- •TNBC: no more than 2 prior chemotherapeutic regimens in the locally advanced or metastatic setting
- •HR+/Her2-: no more than 2 prior chemotherapeutic regimens and no more than 1 prior PI3K inhibitor (PIKi) in the locally advanced or metastatic setting
- •In Arm 2: S64315 + eribulin
- •-Histologically confirmed locally advanced or metastatic TNBC or HR+/Her2- BC (HR+ (Estrogen or Progesterone) > 10% and Her2- (score 0 or 1 by immunochemistry), FISH (Fluorescence In Situ Hybridization) negative if IHC (immuno-histochemistry) score 2):
- •TNBC: no more than 2 prior chemotherapeutic regimens in the locally advanced or metastatic setting
- •HR+/Her2-: no more than 2 prior chemotherapeutic regimens and no more than 1 prior PI3Ki in the locally advanced or metastatic setting
- •-No prior exposure to eribulin in the adjuvant, neoadjuvant or metastatic setting
- •In Arm 3: S64315 + fulvestrant
- •-Histologically confirmed locally advanced or metastatic HR+/Her2- BC: (HR+ (Estrogen or Progesterone) > 10% and Her2- (score 0 or 1 by mmunochemistry), FISH (Fluorescence In Situ Hybridization) negative if IHC (immuno-histochemistry) score 2)
- •No more than two prior lines of hormonal therapy in the locally advanced or metastatic setting
- •Prior treatment with CDK4/6 inhibitor (CDK4/6i) is permitted
- •Prior treatment with PI3K inhibitor (PI3Ki) is permitted
- •Patients for whom endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at the time of entry into the study, as per national or local treatment guidelines
- •-Post-menopausal women
- •For all patients:
- •-Patient must have at least one measurable lesion, as defined by revised RECIST v1.1, 2009
- •-Estimated life expectancy = 12 weeks
- •-Eastern Cooperative Oncology Group (ECOG) performance status = 1
- •-Adequate haematological function based on the last assessment performed within 7 days prior to the first IMP administration.
- •-Adequate renal function based on the last assessment performed within 7 days prior to the first IMP administration.
- •-Adequate hepatic function based on the last assessment performed within 7 days prior to the first IMP administration.
- •-Serum CK/CPK = 2.5 ULN
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 174
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 116
排除标准
- •-Only for Arm 1 and 2: Pregnant and lactating women
- •-Patients who have not recovered from toxicity of previous anticancer therapy, including grade = 2 non-haematologic toxicity, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 5.00), prior to the first IMP administration Certain toxicities will not be considered in this category (e.g. alopecia)
- •-Severe or uncontrolled active acute or chronic infection
- •-Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, active viral or other hepatitis or cirrhosis
- •-Medical history of acute or chronic pancreatitis
- •-Unresolved diarrhoea = CTCAE Grade 2 or presence of medical condition associated with chronic diarrhoea (such as irritable bowel syndrome, inflammatory bowel disease)
- •-Clinically significant cardiac dysfunction (including NYHA Class = II heart failure, left ventricular ejection fraction (LVEF) < 50% as assessed by echocardiography or Multi Gated Acquisition Scan (MUGA))
- •-Uncontrolled arterial hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 95 mmHg despite treatment)
- •-Acute coronary syndrome including unstable angina pectoris (anginal symptoms at rest), new onset angina, acute myocardial infarction, coronary artery bypass graft (CABG) within 3 months prior to starting study treatment
- •-Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block)
- •-Congenital or substance-induced long QT defined as QTc interval > 450 ms for males and > 470 ms for females according to Frederica’s formula
- •-Troponin (I or T) > ULN
- •-Patients with coagulopathy that will increase the risk of bleeding complications according to investigator’s judgment (e.g. disseminated intravascular coagulation)
- •-Known hypersensitivity to paclitaxel /eribulin /fulvestrant or S65315 including excipients of the liposomal vehicle, eggs or soybean
- •-Only for Arm 1 and Arm 2: Evidence of peripheral neuropathy = CTCAE grade 2
- •-Major surgery (involving a risk to the life of the patient) within 4 weeks prior to the first dose of IMP, or patients who have not recovered from side effects of the surgery
- •-Any radiotherapy within 2 weeks before the first dose of IMP (except for palliative radiotherapy at localised lesions)
研究者
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