A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 171
- 试验地点
- 11
- 主要终点
- Part 1: Dose Escalation
研究概览
简要总结
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
详细描述
This Phase 1/1b study is evaluating the safety, tolerability, and preliminary anticancer activity of ST-01156 in participants with advanced solid malignancies. The study will be conducted in 2 parts. Part 1 (Dose Escalation) will assess the safety, tolerability, pharmacokinetics (PK) and preliminary anticancer activity of SD-01156 in participants with advanced solid malignancies, many of whom have a biological rationale to be targeted with an inhibitor of RBM39. Part 1 will also seek to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of ST-01156.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years on the day of signing the consent form, except for adolescents with Ewing Sarcoma or other malignancies for which there is a biological rationale to support participation, in which case the participant is ≥ 16 years old.
- •Has a metastatic or locally advanced and unresectable solid tumor.
- •Has at least 1 measurable lesion or evaluable disease per RECIST v1.
- •Has an ECOG performance status ≤ 2 at screening.
- •Has adequate organ function as defined in the protocol.
排除标准
- •Has received prior radiotherapy within 2 weeks of treatment.
- •Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate, provided they are radiologically stable
- •Has received treatment with any local or systemic anticancer therapy or investigational anticancer agent within 14 days or 5 half-lives, whichever is shorter.
- •Had major surgery within 28 days before study therapy administration
- •Has toxicities from previous anticancer therapies that have not resolved to baseline levels, with the exception of alopecia and peripheral neuropathy.
- •Has previously received a RBM39 inhibitor/degrader.
研究组 & 干预措施
Dose Escalation
ST-01156, administered orally once daily for 5 consecutive days followed by 2 days without study drug administration every 7 days
干预措施: ST-01156 (Drug)
结局指标
主要结局
Part 1: Dose Escalation
时间窗: Duration of treatment period
To identify the maximum tolerated dose (MTD) or maximum administered dose (MAD), and to recommend a dose for subsequent studies (recommended Phase 2 dose \[ RP2D\]) of ST-01156 on a daily oral schedule for 5 consecutive days out of every 7 days with a cycle defined as 28 days (4 weeks).
Part 1: Dose Escalation
时间窗: First 28 days of treatment
To characterize the safety, tolerability, and adverse event (AE) profile of escalating doses of ST-01156 administered for 5 consecutive days followed by 2 days without study drug administration every 7 days, with a cycle defined as 28 days (4 weeks).
次要结局
- Part 1: Dose Escalation(Baseline and every 6 weeks thereafter until disease progression)
- Part 1: Dose Escalation(First 28 days of treatment)