ISRCTN13713551进行中（未招募）1 期
A phase IA/B open-label study to evaluate safety, pharmacokinetics, and preliminary clinical activity of RO7276389 alone and in combination with cobimetinib in participants with Braf-V600 mutation-positive advanced solid tumor or Braf-V600 mutation-positive melanoma with central nervous system metastases
Roche (United States)0 个研究点目标入组 292 人开始时间: 2021年12月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 292
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
- 性别
- All
入选标准
- •1. Have Eastern Cooperative Oncology Group (ECOG) Performance Status =2
- •2. Aged =18 years at the time of signing Informed consent form (ICF)
- •3. Life expectancy of >3 months
- •4. Documented BRAF-V600 mutation status of tumour tissue preferentially using an FDA-approved or CE-IVD genetic test
- •5. Confirmation of availability of archival tumour tissue for submission to the sponsor/central laboratory
- •For Part 1 only:
- •1. Participants with histologically confirmed advanced/metastatic solid tumour or brain metastases with the measurable systemic disease per RECIST v1.1 (extracranial disease) or mRECIST-BM (intra-cranial disease)
- •For Part 2 only:
- •1. Participants with histologically confirmed cutaneous melanoma with radiologically confirmed asymptomatic brain metastases per mRECIST-BM
- •2. Stable or improved CNS disease symptoms for at least 14 days before the start of study treatment
排除标准
- •Current exclusion criteria as of 01/08/2022:
- •1. For Part 2 only: History of or current leptomeningeal metastases
- •2. Any metastasis requiring immediate local intervention
- •3. Uncontrolled tumour-related pain
- •4. Participants requiring narcotic pain medication must be on a stable regimen at the start of study treatment
- •5. Ascites, pleural effusion, or pericardial effusion requiring medical intervention (including use of diuretics) within 6 months prior to study entry
- •6. Active malignancy (other than the one under investigation) or a prior malignancy within the past two years prior to enrolment with some exceptions
- •7. Active uveitis, or any history of serous retinopathy or retinal vein occlusion
- •8. Current or history of Central Nervous System (CNS) disease unrelated to the malignancy under investigation, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- •9. Active autoimmune disease, or quiescent autoimmune disease with exacerbations/flares within 1 year prior to enrolment
- •10. Systemic anti-cancer therapy or small-molecular therapeutic(s), including but not limited to chemotherapy, investigational drugs, hormonal therapy and radiotherapy, and antibody-based agents all within 2 weeks or at least 5 half-lives, whichever is shorter, prior to start of study treatment
- •11. Treatment with stereotactic radiosurgery or craniotomy within 1 week prior to study treatment or treatment with whole brain radiotherapy within 3 months prior study treatment. Participants with local therapy should have a complete recovery with no neurological sequelae.
- •12. Radiation therapy to visceral metastases within 1 week prior to study treatment. Palliative
- •radiotherapy is allowed.
- •13. Major surgical procedure other than for diagnosis within 2 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
- •14. Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for =2 weeks prior to screening
- •15. Contraindication to cobimetinib or known hypersensitivity to any formulation component of cobimetinib (if applicable)
- •16. Participants with known hypersensitivity to BRAFi and/or MEK inhibitors (MEKi)
- •17. Increasing corticosteroid dose during the 14 days prior to initiation of study treatment or current dexamethasone or equivalent dose of >8 mg/day
- •18. Strong CYP3A inducers (including St. John's wort and hyperforin) are prohibited during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later).
- •19. Concomitant treatment with anti-convulsants other than gabapentin, vigabatrin and
- •levetiracetam are prohibited (e.g., carbamazepine, phenytoin, and phenobarbital due to strong CYP3A induction) during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)
- •20. For combination treatment with cobimetinib, moderate and strong CYP3A inducers and inhibitors are prohibited during study treatment and for 2 weeks after the last dose of cobimetinib or RO7276389 (whichever is later)
- •21. Concomitant treatment with drugs known to shorten the QT interval, e.g. rufinamide
- •22. Uncontrolled diabetes or symptomatic hyperglycemia
- •23. Any Grade =3 haemorrhage or bleeding event within 28 days of study treatment initiation
- •24. History of human immunodeficiency virus (HIV) positivity
- •25. Hepatitis B virus
研究者
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