NCT05241834已完成1 期
A Phase 1 Study of Oral LOXO-260 in Patients With RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation Refractory to Selective RET Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 32
- 主要终点
- Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
研究概览
简要总结
The main purpose of this study is to learn more about the safety, side effects, and effectiveness of LOXO-260. LOXO-260 may be used to treat cancer that has a change in a particular gene (known as the RET gene). Participation could last up to 24 months (2 years) and possibly longer if the disease does not get worse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be ≥ 18 years of age at the time of signing the informed consent (Phase 1a and Phase 1b). Patients 12 years and older may be enrolled in Phase 1b for countries and sites where approved.
- •Must have evidence of a previously documented RET fusion (solid tumors) or RET mutation (MTC or MEN2-associated cancers) that is a histological or a cytological proven diagnosis of locally advanced, unresectable and/or metastatic cancer and meet cohort-specific criteria.
- •Have received a prior selective RET inhibitor.
- •Eastern Cooperative Oncology Group (ECOG) score of 0 to 1 (age > 16 years), Karnofsky Performance Status (KPS) ≥ 80 (age > 16 years), or Lansky Performance Status (LPS) ≥ 40% (age < 16 years).
- •Have discontinued all previous treatments for cancer with resolution of any significant AEs, and of all clinically significant toxic effects of prior locoregional therapy, surgery, radiotherapy, or systemic anticancer therapy.
- •Have adequate organ function.
- •Phase 1b expansion: Patients must have measurable disease per RECIST v 1.
- •Phase 1b expansion: Molecular Pathology Results (including RET and other genes) from a sample, blood or tissue, taken on or after RET selective treatment.
排除标准
- •Disease suitable for local therapy administered with curative intent.
- •Have an active fungal, bacterial, and/or active untreated viral infection.
- •The patient has a serious pre-existing medical condition(s).
- •Have symptomatic CNS malignancy or metastasis.
- •Patients treated with drugs known to be strong inhibitors or inducers of cytochrome P450 3A (CYP3A).
- •Progression of disease within 4 months of starting a prior selective RET inhibitor.
- •Phase 1b expansion: Patients harboring known activating bypass alterations outside RET that may confer resistance to LOXO-260.
研究组 & 干预措施
Phase 1B: LOXO-260 Dose Expansion
Experimental
LOXO-260 administered orally
干预措施: LOXO-260 (Drug)
Phase 1A: LOXO-260 Dose Escalation
Experimental
LOXO-260 administered orally
干预措施: LOXO-260 (Drug)
结局指标
主要结局
Phase 1 a: To determine the MTD/RP2D of LOXO-260: Dose limiting toxicity (DLT) rate
时间窗: During the first 28-day cycle of LOXO-260 treatment
DLT rate
次要结局
- Phase 1b: To assess the antitumor activity: Overall response rate (ORR)(Up to approximately 24 months or 2 years)
- To characterize the PK properties of LOXO-260: Mean concentration of LOXO-260(Up to approximately 24 months or 2 years)
- To assess the antitumor activity of LOXO-260: ORR(Up to approximately 24 months or 2 years)
研究者
研究点 (32)
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