ACTRN12623000202662撤回1 期
A First-in-Human (FIH), Open-Label, Phase Ia Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Subjects with Advanced/Metastatic Solid Tumours that have relapsed or are refractory/intolerant to standard of care therapies
Qurgen Australia Pty Ltd0 个研究点目标入组 48 人开始时间: 2023年2月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1.Participants are required to have:
- •a.Histological confirmed locally advanced or metastatic solid tumour, that is relapsed, refractory, or intolerant to currently approved therapies.
- •b.Measurable or evaluable disease by RECIST v1.1.
- •2.Willing and be able to understand and to sign an informed consent form (ICF) and to comply with all aspects of the protocol.
- •3.Female or male participants aged greater than or equal to 18 years.
- •4.Participants who use tobacco products can be included only if they agree that the use of nicotine- containing products (including nicotine patches) will not be permitted while they are in the study centre.
- •5.The ECOG performance status less than or equal to 1.
- •6.Life expectancy greater than 3 months in the Investigator’s opinion.
- •7.Participants must be candidates for and agree to the placement of a central venous access line and further must be able, in the opinion of the Investigator, to manage care of this line.
- •8.Participants with treated brain metastases are allowed but should be neurologically stable (for 4 weeks post-treatment as assessed by central nervous system (CNS) imaging and prior to study enrolment) and off steroids for at least 2 weeks before administration of any study treatment.
- •9.Adequate hepatic/renal function
- •10.Adequate haematological function
- •11.Coagulation tests within an acceptable range
排除标准
- •1. Participation in an interventional, investigational study within 2 weeks or 5 half-lives, whichever is shorter of the first dose of study treatment.
- •2.Presence of overt leptomeningeal or active CNS metastases or primary tumour or CNS metastases that require local CNS-directed therapy (e.g., radiotherapy or surgery) or increasing doses of corticosteroids within the prior 2 weeks.
- •3.Impaired cardiac function or clinically significant cardiac disease, including any of the following:
- •a.Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association [NYHA] Grade greater or equal to 2), left ventricular ejection fraction (LVEF) less than 50% as determined by multiple gated acquisition (MUGA) or echocardiogram (ECHO), recorded in medical history of last two years or clinically significant arrhythmia.
- •b.QT interval corrected for heart rate using Fridericia’s formula (QTcF) greater than 470 ms ECG or congenital long QT syndrome at the Screening Visit.
- •c.Acute myocardial infarction or unstable angina pectoris less than 6 months prior to the first dose of study drug.
- •4.Uncontrolled hypertension (systolic blood pressure greater than 150 mmHg and diastolic blood pressure greater than 100 mmHg), or in the opinion of the Investigator: a recent history of hypertension crisis, or a recent history of hypertensive encephalopathy.
- •5.History of stroke or clinically significant intracranial haemorrhage within 6 months before first dose of study drug.
- •6.Participants with active human immunodeficiency virus (HIV) infection or if subject has a history of HIV, subject must be confirmed to not have active infection.
- •7.Participants who have active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection.
- •8.Chronic liver disease or chronic hepatitis (Child-Pugh Class B or C hepatic impairment).
- •9.Prior or current malignant disease other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; adequately treated cervical carcinoma-in-situ completely resected basal cell or squamous cell skin cancers; any malignancy considered to be indolent and that has never required therapy; and completely resected carcinoma in situ of any type.
研究者
相似试验
进行中（未招募）
1 期
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Amivantamab (JNJ61186372), a Human Bispecific EGFR and cMet Antibody, in Participants with Advanced Non-Small Cell Lung CancerCTIS2023-509435-11-00Janssen Cilag International660
进行中（未招募）
1 期
A first-in-human dose escalation and expansion study to evaluate the safety, and tolerability of AZD8421 alone or in combination in participants with selected advanced or metastatic solid tumors.Patients with ER+ HER2- advanced breast cancer and patients with high-grade serious ovarian cancer (HGSOC)CTIS2023-507305-33-00Astrazeneca AB204
进行中（未招募）
1 期
First trial testing safety and efficacy of IMGN151 in women with recurrent endometrial and ovarian cancerRecurrent Endometrial Cancer and Recurrent, High-Grade Serous Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube CancersMedDRA version: 20.0Level: PTClassification code: 10016180Term: Fallopian tube cancer Class: 100000004864MedDRA version: 20.0Level: PTClassification code: 10061328Term: Ovarian epithelial cancer Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10014736Term: Endometrial cancer recurrent Class: 100000004864CTIS2023-506842-22-00Immunogen Inc.259
已完成
1 期
A Phase 1a / 1b Study of Oral TP-0903 in Patients with Advanced Solid Tumorsadvanced metastatic or progressive solid tumor(s)JPRN-jRCT2080224717Sumitomo Pharma Co., Ltd.160
进行中（未招募）
1 期
A Phase 1 study of anti-HER3 monoclonal antibody GSK2849330, in subjects with advanced HER3-positive solid tumors.EUCTR2013-001699-39-NLGlaxoSmithKline Research Development Ltd154