A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients With Advanced Tumors and Lymphomas
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Curis, Inc.
- 入组人数
- 71
- 试验地点
- 19
- 主要终点
- Maximum tolerated dose (MTD) of CA-170
研究概览
简要总结
CA-170 is a rationally designed and orally available, small molecule that directly targets the Programmed death-ligands 1 and 2 (PD-L1/PD-L2), and V-domain Ig suppressor of T cell activation (VISTA) immune checkpoints and results in activation of T cell proliferation and cytokine production. This is a multi-center, open-label, Phase 1 trial of orally administered CA-170 in adult patients with advanced solid tumors or lymphomas who have progressed or are non-responsive to available therapies and for which no standard therapy exists.
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
- •Males and females ≥ 18 years of age;
- •Life expectancy of at least 3 months;
- •ECOG PS ≤ 1;
- •Acceptable bone marrow and organ function at screening;
- •Ability to swallow and retain oral medications;
- •Negative serum pregnancy test in women of childbearing potential;
- •Measurable disease;
- •Tumor for which standard therapy, including approved anti-PD-1 or anti-PD-L1 therapy, when applicable, does not exist or is no longer effective. For patients enrolling into backfill of dose levels at or below the MTD/RP2D, patients with tumor types known to have a high VISTA expression (such as metastatic malignant pleural mesothelioma of epithelioid histology).
排除标准
- •Prior treatment anti-cancer therapy or use of any investigational agent within the past 28 days or 5 half-lives, whichever is shorter;
- •Toxicity from prior chemotherapy that has not resolved to Grade ≤ 1;
- •Radiotherapy within the last 21 days;
- •Primary brain tumors or CNS metastases;
- •Major or minor surgery < 28 and <14 days from the start of treatment, respectively;
- •Active autoimmune disease or any medical condition requiring the use of systemic immunosuppressive medications;
- •Endocrinopathies, unless on stable hormone replacement therapy;
- •Active infection requiring systemic therapy;
- •Receipt of live vaccines against infectious diseases within 28 days;
- •HIV positive or an AIDS-related illness;
- •Active/chronic HBV or HCV infection;
- •Uncontrolled CHF (NYHA Class 2-4), angina, MI, CVA, coronary/peripheral artery bypass graft surgery, TIA, or PE in prior 3 months;
- •Cardiac dysrhythmias;
- •Gastrointestinal disease that interferes with receipt of oral drugs;
- •Concomitant malignancy;
- •Pregnant or lactating female;
研究组 & 干预措施
CA-170
Taken orally in a once or twice daily schedule.
干预措施: CA-170 (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD) of CA-170
时间窗: Approximately 24 months
The number of patients with a dose-limiting toxicity (DLT) in the first treatment cycle
时间窗: Approximately 24 months
Recommended Phase 2 Dose (RP2D) of CA-170
时间窗: Approximately 24 months
次要结局
- Pharmacokinetic (PK) Profile of CA-170(From Day 1 of Cycle 1(each cycle is 21 days))
- Preliminary Anti-tumor Activity of CA-170 based on RECIST and Immune Related Response Criterion (irRC) for Solid Tumors or Cheson for Lymphoma(36 months)