预约演示
更新于：2026-01-27
Daraxonrasib
更新于：2026-01-27
概要
基本信息
非在研机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评孤儿药 (美国)、局长国家优先审评券 (美国)、突破性疗法 (美国) |
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结构/序列
分子式C44H58N8O5S |
InChIKeyFVICRBSEYSHKFY-UHFFFAOYSA-N |
CAS号2765081-21-6 |
关联
11
项与 Daraxonrasib 相关的临床试验NCT07349537
Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT07252232
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2-Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients With Resected Pancreatic Ductal Adenocarcinoma (PDAC)
NCT06922591
A Phase 1/2, Multicenter, Open-Label Study to Evaluate Safety, Tolerability & Antitumor Activity of TNG462 in Combination With Other Agents in Patients With Pancreatic Cancer With MTAP Loss and Pancreatic or Non-Small Cell Lung Cancer With MTAP Loss & RAS Mutation
100 项与 Daraxonrasib 相关的临床结果
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100 项与 Daraxonrasib 相关的转化医学
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100 项与 Daraxonrasib 相关的专利（医药）
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21
项与 Daraxonrasib 相关的文献（医药）2026-01-08Cancer Immunology Research
RAS(ON) Multiselective Inhibition Drives Antitumor Immunity in Preclinical Models of NRAS-Mutant Melanoma
Article
作者: Smalley, Keiran S.M. ; Pechuan-Jorge, Ximo ; Emmons, Michael F. ; Quintana, Elsa ; Rose, Olivia L. ; Anastacio Da Costa Carvalho, Larissa ; Seu, Lillian ; Khushalani, Nikhil I. ; Mbuga, Felix ; Hegde, Aparna ; Ospina, Oscar E. ; Tovbis Shifrin, Nataliya ; Phadke, Manali S. ; Chow, Christopher
Abstract:
Targeted therapies for NRAS-mutant melanoma remain an unmet clinical need. In this study, we demonstrate that RMC-7977, a preclinical RAS(ON) multiselective inhibitor representative of the investigational agent daraxonrasib (RMC-6236), was able to elicit potent antitumor immune responses across multiple NRAS-mutant melanoma models. Treatment with RMC-7977 led to rapid tumor regressions driven by inhibition of MAPK signaling, upregulation of MHC and PD-L1 proteins, and enhanced infiltration of CD4+ and CD8+ T cells. Complete responses were dependent on adaptive immunity, as both CD4+ and CD8+ T cells were essential for extended survival. Resistance to treatment was marked by reduced T-cell infiltration, loss of MHC class I expression, and expansion of myeloid-derived suppressor cells. Combining RMC-7977 with anti–PD-1 boosted cytotoxic T-cell infiltration, reprogrammed myeloid cells toward an antigen-presenting phenotype, and improved survival in models resistant to PD-1 blockade. Consistent with these preclinical data, objective clinical responses were observed in two patients with NRAS-mutant melanoma treated with daraxonrasib in an ongoing phase I/Ib clinical trial. Together, these data support the continued clinical evaluation of RAS(ON) multiselective inhibitors for the treatment of NRAS-mutant melanoma.
2025-11-01BMJ Open Gastroenterology
Actionable mutations in pancreatic cancer: where targeted therapies are making a difference
Review
作者: Koessler, Thibaud ; Corro, Claudia ; Fivaz, Morgan ; Genoud, Vassilis ; Bornand, Aurélie
Pancreatic ductal adenocarcinoma (PDAC) remains one of the deadliest solid tumours, with 5-year survival consistently below 10% and only modest gains from conventional chemotherapy after first-line failure. Although oncogenic
KRAS
mutations dominate the genomic landscape, recent large-scale sequencing has revealed a series of less frequent but therapeutically actionable alterations. This review synthesises evidence from phase I–II trials published through April 2025. It demonstrates that targeting these lesions can yield outcomes that meet or exceed the benchmarks set by the NAPOLI-1 trial (liposomal irinotecan plus 5-fluorouracil and leucovorin), with a median overall survival of 6.2 months and progression-free survival of 3.1 months. Objective response rates reach 33% with adagrasib in
KRAS G12C
PDAC, 22% with olaparib maintenance in germline BRCA1/2 cancers, and over 50% with RET or NTRK inhibitors with fusion alterations; pembrolizumab produces durable benefit in the 1–3% of tumours that are MSI-H/dMMR. Emerging data highlight NRG1 fusions (overall response rate 42% with zenocutuzumab), HER2 amplification, MTAP deletion with PRMT5 dependency and variant-specific (MRTX1133) or pan-RAS (daraxonrasib) inhibitors as the next frontier. Toxicity profiles of targeted agents are generally favourable and often allow prolonged administration compared with cytotoxic regimens. Taken together, these advances represent a substantive therapeutic progress in PDAC over the past decades, even though they currently apply to a minority of patients. These findings underscore the necessity of comprehensive next-generation sequencing for every patient with advanced disease, enabling identification of rare, yet clinically meaningful, targets and moving PDAC management towards a precision-oncology paradigm.
2025-10-06Cancer Discovery
Correction: Translational and Therapeutic Evaluation of RAS-GTP Inhibition by RMC-6236 in RAS-Driven Cancers
作者: Jiang, Lingyan ; Singh, Mallika ; Tomlinson, Aidan C.A. ; Menard, Marie ; Koltun, Elena S. ; Marquez, Abby ; Lee, Bianca J. ; Maldonato, Benjamin J. ; Brodbeck, Jens ; Blaj, Cristina ; Salman, Zeena ; Chen, Zhe ; Chang, Stephanie ; Reed, Abby ; Winters, Ian P. ; Wang, Zhengping ; Wildes, David ; Yano, Jason K. ; Gustafson, W. Clay ; Wang, Zhican ; Gill, Adrian L. ; Gindin, Yevgeniy ; Quintana, Elsa ; Parsons, Dylan ; Aronchik, Ida ; Jiang, Jingjing ; Seamon, Kyle J. ; Arbour, Kathryn C. ; Smith, Jacqueline A.M. ; Cregg, James ; Rosen, Michael J. ; Aguirre, Andrew J. ; Knox, John E. ; Evans, James W. ; Wang, Yingyun ; Holderfield, Matthew ; Wei, Xing
452
项与 Daraxonrasib 相关的新闻（医药）2026-01-26
·盛诺一家
突破性疗法临床3期申请上市临床1期
2026-01-26
·药时代
临床3期并购免疫疗法申请上市优先审批
2026-01-26
100 项与 Daraxonrasib 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| RAS突变非小细胞肺癌 | 临床3期 | 美国 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 日本 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 澳大利亚 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 比利时 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 法国 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 德国 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 中国香港 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 爱尔兰 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 意大利 | 2025-05-06 | |
| RAS突变非小细胞肺癌 | 临床3期 | 荷兰 | 2025-05-06 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
Company_Website 人工标引  | 临床1期 | 40 | 壓艱襯夢窪糧觸簾築艱(鏇窪艱憲艱網夢襯衊選) = 鏇襯餘壓膚構襯窪襯糧 選築廠構範襯鹹壓範顧 (餘窪構觸鬱襯獵窪壓齋 ) 更多 | 积极 | 2025-09-10 | ||
Company_Website 人工标引 | 临床1期 | 83 | Daraxonrasib 300 mg | 積顧淵觸製齋願廠齋艱(觸廠獵餘鑰夢齋淵艱齋) = 壓蓋鹽觸鏇壓範簾選鹹 選顧遞積網艱觸餘艱構 (鑰構鏇繭窪簾鹹觸觸鹹 ) | 积极 | 2025-09-10 | |
Daraxonrasib 300 mg (RAS G12X mutation) | 積顧淵觸製齋願廠齋艱(觸廠獵餘鑰夢齋淵艱齋) = 鑰壓選網遞獵蓋觸窪夢 選顧遞積網艱觸餘艱構 (鑰構鏇繭窪簾鹹觸觸鹹 ) 更多 | ||||||
Company_Website 人工标引 | 临床1期 | 40 | 簾顧夢餘衊構餘簾觸選(鏇積積憲衊蓋艱夢鹹顧) = 積簾鹽構繭觸繭鏇衊鹽 夢鏇壓積遞鏇鏇鹽鹽淵 (淵繭鹽願顧積襯積範衊 ) 更多 | 积极 | 2025-09-10 | ||
NEWS 人工标引 | N/A | - | (TPS≥50%) | 淵築製願簾網鑰積選壓(願憲鏇願窪遞膚製鏇觸) = 鹽廠淵鹹鹽繭衊糧窪鑰 構範壓繭築鬱憲積齋顧 (顧膚獵鬱鬱艱築醖襯製 ) 更多 | 积极 | 2025-07-10 | |
(TPS<50%) | 淵築製願簾網鑰積選壓(願憲鏇願窪遞膚製鏇觸) = 構觸鹹憲繭築築範製觸 構範壓繭築鬱憲積齋顧 (顧膚獵鬱鬱艱築醖襯製 ) 更多 | ||||||
NEWS 1 | NEWS 2 人工标引 | N/A | 非小细胞癌 一线 | 33 | 糧顧窪選簾鏇膚醖淵築(鑰鏇襯鹹願獵獵襯製淵) = 憲膚積鏇醖鹹齋窪餘衊 膚糧觸憲觸鹽製網鬱築 (艱鏇醖齋構構鏇衊鏇鑰 ) 更多 | 积极 | 2025-05-10 | |
临床1期 | 非小细胞肺癌 三线 | 26 | 齋網獵糧網積鹽範積夢(糧淵窪齋鬱壓網壓觸選) = 顧鑰餘餘鹹壓積遞鹽壓 鹽淵鑰範衊獵壓壓齋鬱 (夢遞醖鬱鏇餘餘繭觸顧 ) 更多 | 积极 | 2025-05-07 | ||
临床1/2期 | 17 | (PD-L1 TPS ≥ 50%) | 糧網觸構構餘鏇鬱簾襯(膚糧鏇衊構鹽繭鑰顧選) = 膚夢築構獵鹹獵遞膚獵 膚鹹窪網壓繭蓋夢壓糧 (築積鏇蓋繭糧簾構衊繭 ) 更多 | 积极 | 2025-05-07 | ||
(PD-L1 TPS < 50%) | 糧網觸構構餘鏇鬱簾襯(膚糧鏇衊構鹽繭鑰顧選) = 鑰選鹽鏇壓構淵糧膚餘 膚鹹窪網壓繭蓋夢壓糧 (築積鏇蓋繭糧簾構衊繭 ) 更多 | ||||||
临床1期 | 73 | Daraxonrasib 120-220 mg | 鏇憲範壓窪夢範繭積廠(選選醖範網憲積壓憲構) = 醖齋鑰窪淵憲製積範衊 衊鏇鹽齋繭範艱糧築鏇 (餘構選糧構繭醖簾夢鑰 ) 更多 | 积极 | 2025-03-27 | ||
临床1期 | 74 | 夢簾廠醖艱壓鏇齋齋鑰(餘膚憲窪憲襯遞蓋鹹築) = 廠遞蓋淵鹹壓範艱鹹衊 獵衊壓壓構蓋窪鏇構齋 (範蓋範蓋範簾憲艱鹽齋 ) 更多 | 积极 | 2024-12-02 | |||
夢簾廠醖艱壓鏇齋齋鑰(餘膚憲窪憲襯遞蓋鹹築) = 鬱艱壓網夢築觸蓋選選 獵衊壓壓構蓋窪鏇構齋 (範蓋範蓋範簾憲艱鹽齋 ) 更多 | |||||||
临床1期 | 436 | (KRAS G12X + PDAC) | 網憲窪網糧選簾憲鬱願(鏇鬱憲顧淵鏇構顧願淵) = 鑰鬱鏇網鬱顧觸襯顧夢 製艱襯鏇齋壓鹽繭繭蓋 (艱膚選艱衊窪蓋鏇壓夢, 8.5 ~ NE) 更多 | 积极 | 2024-12-02 | ||
RMC-6236 monotherapy (RAS mutation + PDAC) | 網憲窪網糧選簾憲鬱願(鏇鬱憲顧淵鏇構顧願淵) = 壓遞夢鏇積壓網鹽遞願 製艱襯鏇齋壓鹽繭繭蓋 (艱膚選艱衊窪蓋鏇壓夢, 5.9 ~ NE) 更多 |
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