ACTRN12623000956606招募中1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacology, and Preliminary Efficacy of AT-0174 in Subjects with Advanced Solid Malignancies
Antido Therapeutics (Australia) Pty Ltd0 个研究点目标入组 33 人开始时间: 2023年9月4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
- 33
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
- •Able to understand, sign, and commit to informed consent and to all study procedures
- •- Histological/cytological evidence of one of the following unresectable locally advanced or metastatic solid cancers:
- •a. Non-small cell lung carcinoma
- •b. Small cell lung carcinoma
- •c. Triple-negative breast carcinoma
- •d. Malignant melanoma
- •e. Gastric carcinoma/gastroesophageal junction carcinoma/esophageal adenocarcinoma
- •f. Squamous cell carcinoma of the esophagus
- •g. Colorectal carcinoma
- •h. Pancreatic ductal adenocarcinoma
- •i. Epithelial ovarian carcinoma (fallopian, ovarian, primary peritoneal carcinoma)
- •j. Endometrial carcinoma
- •k. Thyroid carcinoma (non-medullary)
- •l. Moderate-high grade astrocytoma (oligodendroglioma, astrocytoma, or anaplastic astrocytoma [Grade 2 or 3] and glioblastoma multiforme [Grade 4])
- •m. Other cancers based on the Investigator’s discretion with Sponsor Medical Monitor’s approval.
- •- Locally advanced unresectable or metastatic disease that is refractory to standard therapy, or for whom no standard therapy exists, and where standard therapy is contraindicated or has been declined by the patient
- •- Measurable or evaluable disease per RECIST v1.1, or Grades 2-4 astrocytoma as per RANO-HGG or RANO-LGG criteria, that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy
- •- Eastern Cooperative Oncology (ECOG) performance status less than or equal to 1
- •- Life expectancy greater than or equal to 3 months
- •- Adhere to contraception requirements where applicable
排除标准
- •- Prior radiotherapy within two weeks of treatment
- •- Treatment with anticancer therapies including cytotoxic chemotherapy, monoclonal antibodies (mAbs), and/or small molecule tyrosine kinase inhibitors within 14 days prior to study therapy administration, or 5 half-lives, whichever is shorter (42 days for prior nitrosourea or mitomycin-C)
- •- Major surgery within 28 days of the Screening visit
- •- Therapeutic radiopharmaceuticals within 8 weeks of treatment
- •- Systemic treatment with either corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the planned first dose of study drug
- •- Clinically significant gastrointestinal disorder that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
- •- Evidence or history of uncontrolled, clinically significant haematological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, coagulation neurologic, dermatologic, autoimmune, or allergic disease
- •- Additional active malignancy that is progressing or has required active treatment within the past 3 years
- •- Known active CNS metastases and/or carcinomatous meningitis
研究者
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