CTIS2023-506228-10-00进行中（未招募）1 期
An Open-label, Phase I/II First-in-Human, Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic and Anti-tumor Activity of ERK1/2 Inhibitor IPN01194 as Single Agent in Adult Participants with Advanced Solid Tumors - CLIN-01194-450
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Pharma
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Participants must be =18 years of age, Participants with histologically confirmed metastatic solid tumour (melanoma, CRC, PDAC or HNSCC) for whom no suitable alternative standard therapy exists, Participants must bear tumours harbouring selected classes of genetic mutations, (MAPKm)., Participants must have measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1, Eastern Cooperative Oncology Group (ECOG)/performance status (PS) of 0 or 1., Participants must consent to the use of archival tumour tissue or, if not available, collection of fresh tumour biopsy at screening, Male and female participants; contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials
排除标准
- •Gastrointestinal conditions that could impair absorption of IPN01194 or inability to swallow oral medications, Non-adequate bone marrow function, Non-adequate renal function, Any evidence of severe active infection or inflammatory condition, Non-adequate hepatic function, Non adequate coagulation function, Known uncontrolled human immunodeficiency virus (HIV) infection or hepatitis B or C, Sensitivity to IPN01194 or any of its components, Non-adequate cardiac function, Have one or more of study defined ophthalmological findings/conditions, Known psychiatric or substance abuse disorder, or any other cognitive disorder per the opinion of the investigator that would interfere with the participant’s ability to cooperate with the requirements of the study, Active brain metastases or leptomeningeal metastases, Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will obscure the interpretation of toxicity determination or AEs, Known second malignancy within the last 2 years prior to first dose of study intervention, Major surgery within 28 days prior to first dose of study intervention, Ongoing AEs caused by any prior anti-cancer therapy =Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0)., France-specific: participants under court protection, not affiliated to a social security system or protected adults., Current enrolment or past participation in any other clinical trial involving an investigational study treatment within the last 28 days, Live vaccine(s) within 28 days prior to first dose of study intervention, Concurrent treatment with any other anti-cancer therapy (including radiotherapy or investigational agents)., Treatment with medications that prolong the QT/QTc interval, Treatment with strong and moderate CYP3A4 inducers, Treatment with strong or moderate inhibitors of CYP3A4, ONLY for Phase I participants assigned to dose escalation and low-dose backfill participants: treatment with proton pump inhibitors within 14 days prior to first dose of study intervention.
研究者
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