NCT07612891招募中1 期
A Phase 1 and Phase 2, First-in-Human, Multi-Center, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
Shenzhen Ionova Life Sciences Co., Ltd.1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2025年7月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 201
- 试验地点
- 1
研究概览
简要总结
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) advanced/metastatic breast cancer or locally advanced/metastatic solid tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Written informed consent obtained.
- •Adult patients aged ≥ 18 years.
- •Patients with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors, who have disease progression following standard-of-care therapy, are intolerant to standard treatment, or have no available standard treatment options (e.g., HR+/HER2- breast cancer, Cyclin E1-overexpressing solid tumors and other solid tumors).
- •Agree to provide available archived FFPE tumor tissue specimens or voluntarily accept pre-treatment tumor biopsy (Phase Ⅱ).
- •Have RECIST 1.1-defined measurable lesions.
- •Has a life expectancy of > 3 months.
- •ECOG performance status 0-
- •Adequate marrow, liver and kidney function.
- •Meet the study's specified contraceptive requirements.
排除标准
- •Have a second primary malignancy.
- •Patients with primary CNS tumors or CNS metastases with prior local treatment failure.
- •Have received any anti-tumor therapy or participated in other therapeutic clinical trial within 28 days prior to the first dose of study drug.
- •Has undergone major surgery within 28 days prior to the first dose of study drug.
- •Prior anti-tumor therapy-related toxicities have not recovered to protocol-specified grades.
- •Diagnosed with immunodeficiency or received any form of immunosuppressive therapy within 7 days prior to the first dose.
- •Patients with other severe and persistent underlying medical conditions as assessed by the Investigator.
- •Have protocol-defined clinically significant cardiovascular diseases.
- •Prolonged QTcF interval.
- •Have any medical conditions likely to impair digestion and absorption of the investigational product.
- •Patients with poorly managed blood glucose levels and blood pressure.
- •Clinically significant abnormal serum potassium or sodium as judged by the investigator.
- •Have experienced a severe concurrent infection 14 days prior to the first dose of study drug.
- •Confirmed infection with HIV, HBV or HCV.
- •Are currently receiving any other investigation agent.
- •Have received prior CDK2 inhibitors.
- •Patients with known hypersensitivity to the study drug or any of its components.
- •History of allogenic tissue or solid organ transplant.
- •Are unwilling or unable to comply with procedures required in this protocol.
- •Has other severe systemic diseases or for other reasons deemed ineligible for participation in this clinical trial by the investigator.
研究者
研究点 (1)
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