ACTRN12621001172897招募中1 期
A phase 1 dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of ACT001 in patients with advanced solid tumors (PART B).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 21
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. Histologically or cytologically confirmed advanced or metastatic glioblastoma with no standard treatment options.
- •2. Patients with recurrent glioblastoma who satisfy all of the following may be
- •- Progressive tumor despite prior treatment with radiation therapy and
- •temozolomide
- •- Measurable disease by Response Assessment in Neuro-Oncology (RANO)
- •criteria using gadolinium-enhanced MRI scanning
- •- Either on no glucocorticoids or on a stable dose for 7 days prior to the first
- •dose of study therapy that is equivalent to = 12.5 mg of prednisone daily
- •- No evidence of intracranial hemorrhage (except for stable grade 1
- •hemorrhage), not receiving therapeutic anticoagulation or anti-platelet
- •therapy, and have a normal INR and APTT
- •- No radiation in the past 3 months
- •3. Male or female and at least 18 years of age.
- •4. Adequate organ function (ANC greater than or equal to 1.5 × 109 /L, lymphocytes greater than or equal to 0.5 × 109 /L,
- •platelets greater than or equal to 75 × 109 /L, Hb greater than or equal to 10 g/dl; total bilirubin less than or equal to 1.5 × institutional upper
- •limit of normal (ULN); ALT and AST less than or equal to 2.5 × ULN (less than or equal to 5.0 × ULN if liver metastasis); plasma creatinine less than or equal to 1.5 × ULN; QTc < 450 ms (male), < 470 ms (female).
- •5. A life expectancy of at least 12 weeks.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- •7. Female subjects are eligible if they are of:
- •a) Non-childbearing potential, defined as
- •- Previous hysterectomy or bilateral oophorectomy
- •- Previous bilateral tubal ligation
- •- Post-menopausal (total cessation of menses for greater than or equal to 1 year)
- •b) Childbearing potential with a negative serum pregnancy test at screening
- •(within 7 days of the first investigational product administration), and uses
- •adequate contraception before study entry and throughout the study until 28 days
- •after the last investigational product administration. Adequate contraception,
- •when used consistently and in accordance with both the product label and the
- •instructions of the physician, are defined as follows:
- •- Vasectomized partner who is sterile prior to the female patient’s enrolment
- •and is her sole sexual partner
- •- An intrauterine device with a documented failure rate of less than 1% per
- •- Double barrier contraception defined as condom with a female diaphragm
- •8. Male patients, if sexually active, must agree to use a highly-effective method of
- •contraception (< 1% failure rate per year) with their female partners
- •9. Provided written informed consent prior to enrollment.
排除标准
- •-The patient has an uncontrolled infection.
- •-The patient has serious diseases or stroke within 6 months prior to enrolment.
- •-The patient has a gastrointestinal absorption disorder or cannot take oral drugs.
- •-Uncontrolled brain metastases or spinal cord compression. Patients who were treated with surgical resection or radiation therapy at least 4 weeks earlier are eligible if they are neurologically stable, not taking glucocorticoids and have had an MRI scan performed within the previous 4 weeks showing no tumour progression. (GBM patients taking a steroid dose equivalent to 12.5mg of prednisone are eligible)
- •-Pre-existing allergy to ACT001 or pembrolizumab or related compounds.
- •-Treatment with other cancer therapies such as chemotherapy, biological or targeted therapy, immunotherapy or radiation therapy either currently or within 4 weeks of ACT001 dosing (6 weeks for BCNU, CCNU or mitomycin-C). Pembrolizumab is exempt from this exclusion in Part B
- •-Unresolved toxicity from prior anti-tumour therapy.
- •-Patients with active autoimmune diseases or history of autoimmune diseases except for patients with vitiligo or alopecia, or those with hypothyroidism following autoimmune thyroiditis on a stable replacement dose of thyroid hormone are not excluded.
- •-Patients who have received chronic glucocorticoid treatment at levels above the equivalent of prednisone at > 12.5 mg/day or dexamethasone at > 2 mg/day, or other immunosuppressive medication within 14 days prior to the first dose of the study drug.
- •-Major surgery within 30 days of commencing first study therapy.
- •-Patients who have received organ transplantation
- •-Pregnant or breast-feeding females.
- •-A history of infection with HIV or hepatitis B or C viruses
- •-The subject has participated in other drug clinical trials within 4 weeks prior to informed consent.
- •-The subject is, in the opinion of the investigator, unsuitable for any reason.
研究者
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