A Phase 1 Trial of BTM-3566 in Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Frequency and type of dose limiting toxicities
研究概览
简要总结
The goal of this clinical trial is to learn about what doses of BTM-356 are safe to use in adults with advanced cancers in solid tumors. It will also learn about how effective different doses of BTM-3566 are in treating cancer. The main questions it aims to answer are:
What adverse events and toxicities (harmful side effects) are associated with different doses of BTM-3566? What are the blood levels of BTM-3566 in your body at different timepoints? What effect does BTM-3566 have on reducing tumor size and/or preventing the worsening of cancer? All participants will receive BTM-3566 and none will receive placebo (a look-alike substance that contains no drug).
Participants will:
- Take BTM-3566 for 7 days, then take a 7 day break. This 2 week dosing schedule of 7 days on/7 days off will continue until your disease worsens or you cannot tolerate treatment.
- Visit the clinic approximately 7 times during screening and the first month of treatment. Visits will be reduced to approximately 2 visits per month after.
- Keep a diary of when (and how much) BTM-3566 you take, along with how much you weigh on each dosing day.
详细描述
This study is a phase 1, open label, dose escalation study using single participant cohorts followed by 3+3 design to evaluate multiple ascending doses of BTM-3566.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any advanced, unresectable and/or metastatic solid tumors except for primary brain cancer, breast cancer, prostate cancer, pancreatic cancer, pheochromocytoma, fibrolamellar carcinoma, adrenocortical carcinoma, or ocular or cutaneous melanoma.
- •Must be refractory/relapsed after all standard therapies known to provide proven clinical benefit
- •ECOG Performance Status 0 to 2
- •Adequate organ function as defined by pre-specified laboratory values
- •Life expectancy > 3 months
- •Women of child-bearing potential (or males with female partners of child-bearing potential) must agree to use adequate contraceptive measures throughout the study and for 90 days following last dose
排除标准
- •Has not completed appropriate wash-out timeframes of prior anti-cancer treatments
- •Has ongoing toxicities from prior anti-cancer treatments
- •Has symptomatic or uncontrolled neurologic disease
- •Has active and clinically significant bacterial, fungal or viral infection
- •Cannot avoid use of moderate or strong CYP3A4 inhibitors or inducers; CYP2C19 substrates or OAT2 substrates with narrow therapeutic index; or drugs that prolong the QT interval throughout the study
- •Has previously received a total anthracycline dose ≥ 360mg/m2 doxorubicin or equivalent
- •Has a history of serious cardiac conditions or pulmonary or cerebrovascular events within 6 months of first dose
- •Is pregnant or breastfeeding
研究组 & 干预措施
BTM-3566
Daily oral dosing (7 days on/7 days off)
干预措施: BTM-3566 (Drug)
结局指标
主要结局
Frequency and type of dose limiting toxicities
时间窗: 28 days
Frequency and type of dose limiting toxicities associated with each dose level of BTM-3566
Frequency and severity of adverse events
时间窗: Through study completion, estimated 2 years
Frequency and severity of adverse events according to NCI-CTCAE v 5.0
次要结局
- Pharmacokinetic properties of BTM-3566(30 days)
- Clinical activity of BTM-3566(Through study completion, estimated 2 years)