NL-OMON56188已完成不适用
A Phase 1/1b Open-Label, Multicenter, to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN 2787 in Participants with BRAF and/or NRAS Mutation positive Solid Tumors - KIN-2787Activity in Participants with BRAF/NRASMutation PositiveSolidTumors
Kinnate Biopharma0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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 99（—）
入选标准
- •Key inclusion criteria include the following:
- •General Considerations:
- •1. Adult participants (>= 18 years of age) with histologically or cytologically
- •confirmed diagnosis of metastatic or advanced-stage malignancy will be eligible
- •for this study.
- •2. Participants with brain metastasis that are asymptomatic and do not require
- •treatment in the opinion of the investigator.
- •3. Participants will provide archived tumor tissue specimen (formalinfixed
- •paraffin-embedded [FFPE] specimen) obtained within the last 5 years (if
- •available), and will undergo mandatory pre-treatment
- •tumor biopsy, if medically feasible.
- •4. A participant's tumor must harbor an oncogenic BRAF Class I, II, or III
- •mutation or be melanoma with an NRAS Q61, G12, or G13 positive mutation
- •identified by previous genomic analysis of tumor tissue or ctDNA conducted in a
- •Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (in
- •United States
- •[US]) or in accordance with local regulatory requirements (in other countries).
- •Study Part Specific Considerations - Part A1:
- •1. Participants with any type of advanced or metastatic solid tumor with
- •oncogenic BRAF Class I, Class II or Class III mutations and NRASmut
- •positive melanoma.
- •2, Participants must have received prior standard therapy appropriate
- •for their tumor type and stage of disease, or in the opinion of the
- •Investigator, would be unlikely to tolerate or derive clinically meaningful
- •benefit from appropriate standard of care therapy.
- •3. However, participants may enroll without having been pretreated with
- •a small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy if such
- •treatment has not been approved for that indication.
- •Study Part Specific Considerations - Part A2:
- •1. Participants with NRAS Q61, G12, or G13 positive mutated advanced
- •solid tumors and oncogenic BRAF pretreated Class I, II or III mutated
- •advanced solid tumors
- •2. Participants should have previously received an approved BRAF
- •inhibitor (with or without an approved MEK inhibitor), if authorized and
- •available unless, in the opinion of the Investigator, the participant would
- •be unlikely to tolerate or derive clinically meaningful benefit from that
- •Study Part Specific Considerations - Part B1:
- •1. Participants with unresectable and locally advanced or metastatic
- •NSCLC, melanoma, or any other unresectable and locally advanced solid
- •tumor with oncogenic BRAF Class I, II, or III mutations
- •Study Part Specific Considerations - Part B2:
- •1. Participants with advanced or metastatic solid cancers harboring the
- •NRAS Q61, G12, or G13 mutations or any oncogenic BRAF Class II
- •2. Participants must have received prior standard therapy appropriate
- •for their tumor type and stage of disease, or in the opinion of the
- •Investigator, would be unlikely to tolerate or derive clinically meaningful
- •benefit from appropriate standard of care therapy.
排除标准
- •Key exclusion criteria include the following:
- •. Participants may not have any unresolved toxicities from prior antitumor
- •therapy or significant concomitant diseases.
- •2. In Part B1 and B2, previous treatment with any approved or in-development
- •small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy is excluded.
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