预约演示
更新于：2026-02-03
Dostarlimab-gxly
多塔利单抗
更新于：2026-02-03
概要
基本信息
药物类型 单克隆抗体 |
别名 Dostarlimab、Immunoglobulin G4, anti-programmed cell death protein 1 (PDCD1) (humanized clone ABT1 gamma4-chain), disulfide with humanized clone ABT1 kappa-chain, dimer、多斯塔利单抗 + [11] |
靶点 |
作用方式 抑制剂 |
作用机制 PD-1抑制剂(细胞程序性死亡-1抑制剂) |
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 欧盟 (2021-04-21), |
最高研发阶段(中国)临床3期 |
特殊审评快速通道 (美国)、加速批准 (美国)、优先审评 (澳大利亚)、局长国家优先审评券 (美国)、优先审评 (美国)、突破性疗法 (美国) |
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结构/序列
Sequence Code 315609369H
来源: *****
Sequence Code 315609370L
来源: *****
关联
106
项与 多塔利单抗 相关的临床试验NCT07381777
Phase II Randomized Trial of XELOX Plus DoSTARlimab Versus XELOX Alone as Consolidation Treatment After Standard Chemoradiation in pMMR/MSS or MSI-Low Locally Advanced Rectal Cancer (LARC) Patients - IMMUNOSTAR Trial GOIRC-02-2024
NCT06405230
A Pilot/Exploratory Translational Study to Evaluate Response to Dostarlimab and Pembrolizumab in Extracellular Vesicles (EVs) or Patient-derived Organoids (PDOs) and by Zirconium-89 Labelled Programmed Death Ligand 1 Positron Emission Tomography in Participants With Recurrent Non-small Cell Lung Cancer
NCT07336147
Dostarlimab, Cisplatin and Etoposide in Combination With Radiotherapy in Sandwich Sequence for Small Cell Neuroendocrine Cervical Carcinoma (DICER Trial): Taiwanese Gynecologic Oncology Group (TGOG) 1012
100 项与 多塔利单抗 相关的临床结果
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100 项与 多塔利单抗 相关的转化医学
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100 项与 多塔利单抗 相关的专利（医药）
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189
项与 多塔利单抗 相关的文献（医药）2026-12-31PLATELETS
Immune thrombocytopenia triggered by dostarlimab in a patient with endometrial carcinoma: first reported case
Article
作者: Pazmiño-Zambrano, M. Belén ; García-Jaén, Pablo ; González-Porras, José Ramón ; Bastida, José María ; Fernández-Sánchez, Adolfo ; Reguera-Puertas, Pablo ; Puerta-Vázquez, Carlos
Immune checkpoint inhibitors (ICIs) have transformed the treatment landscape for various malignancies, but they are associated with a range of immunerelated adverse events, including rare hematological complications. Immune thrombocytopenia (ITP) has been reported with other antiPD1 agents such as nivolumab and pembrolizumab, but to date, no cases have been described with dostarlimab. We report the first case of ITP in a patient receiving dostarlimab for relapsed endometrial carcinoma. A 55yearold woman developed severe thrombocytopenia (3 × 109/L) accompanied by rectal bleeding, resulting in a lifethreatening condition. Secondary causes were excluded, and bone marrow findings supported a diagnosis of ITP. Initial treatment with highdose corticosteroids and intravenous immunoglobulin achieved only a partial response, while sustained platelet recovery was obtained with the addition of romiplostim. The patient remained on dostarlimab following hematological recovery without further episodes of ITP. This case highlights a potentially lifethreatening adverse effect of a widely used immunotherapy and underscores the importance of early recognition and timely escalation of treatment in ICIinduced ITP.
2026-02-01Journal of Minimally Invasive Gynecology
Repair of Vesicovaginal Fistula in 12 Steps Using the da Vinci Surgical System
Article
作者: Kogan, Liron ; Dayan-Schwartz, Adi ; Shachor, Noga ; Braverman, Meirav
OBJECTIVE:
To demonstrate the feasibility and effectiveness of a stepwise robotic-assisted vesicovaginal fistula (VVF) repair following oncologic surgery and adjuvant therapy.
SETTING:
University teaching hospital.
PARTICIPANT:
A 60-year-old woman with stage IIIC1, grade 2 endometrial carcinoma developed VVF following total laparoscopic hysterectomy, bilateral salpingo-oophorectomy, sentinel lymph node sampling, and six cycles of carboplatin, paclitaxel, and Dostarlimab.
INTERVENTION:
After failed conservative management with Foley catheter and bilateral nephrostomies, the patient underwent robotic-assisted VVF repair. Conservative management was prolonged beyond the typical 6-week trial to allow completion of adjuvant treatment, with continuous bladder drainage and nephrostomies maintained. This approach is supported by literature indicating early postoperative fistulas may close spontaneously with adequate diversion, particularly when small, uninfected, and not radiation-related [1]. However, persistent leakage, failed closure, and impaired quality of life necessitated surgery. Repair was conducted approximately 6 weeks after primary surgery and adjuvant chemotherapy, during a treatment-free interval. This timing was selected to: (1) allow tissue recovery, (2) confirm absence of active disease, and (3) address significant symptoms and quality-of-life burden. This aimed to optimize tissue condition and vascularity for successful closure while minimizing undue delay in cancer treatment. The VVF repair performed in 12 systematic steps, as detailed in the video.
RESULTS:
The surgery was completed robotically, with removal of the nephrostomy tubes and placement of a Foley catheter, left in place for 14 days. The patient was discharged on postoperative day 1. Follow-up imaging confirmed fistula closure and restored continence. At submission, the patient has 6 months of follow-up with no fistula recurrence, voiding dysfunction, or need for additional urinary diversion.
CONCLUSION:
This case illustrates the efficacy of a stepwise robotic VVF repair, offering precise dissection, enhanced visualization, and successful anatomical and functional restoration. VIDEO ABSTRACT.
2026-01-14Future Oncology
A Phase III study of perioperative dostarlimab in patients with dMMR/MSI-H resectable colon cancer: AZUR-2 study design
Article
作者: Cohen, Daniel N. ; Strickler, John H. ; Starling, Naureen ; Lau, Yong Loo ; Stjepanovic, Neda ; Mendez, Guillermo ; Benson, Al ; Edwards, Ken ; Kawazoe, Akihito ; Tian, Min ; Seligmann, Jenny F. ; Ferreiro, Reyes ; Campbell, Nicole ; Oki, Eiji ; Elez, Elena
The role of perioperative immunotherapy as a chemotherapy-free option for patients with resectable mismatch repair-deficient/microsatellite instability-high (dMMR/MSI-H) colon cancer is evolving, with early-phase neoadjuvant studies reporting favorable long-term outcomes. AZUR-2 is an ongoing global, Phase III, open-label, randomized study evaluating the efficacy of perioperative dostarlimab monotherapy compared with standard of care (SoC) (adjuvant chemotherapy or surveillance) in adult patients with previously untreated, pathologically confirmed, radiologically evaluable T4N0 or Stage III resectable dMMR/MSIH colon adenocarcinoma. Patients will be randomized 2:1 to receive neoadjuvant dostarlimab 500 mg every 3 weeks (4 cycles), followed by surgery, then adjuvant dostarlimab 1000 mg every 6 weeks (6 cycles), or to receive immediate surgery followed by SoC. The primary endpoint is event-free survival assessed by blinded independent central review. The key secondary endpoint is overall survival; additional secondary endpoints include pathological response assessed by residual viable tumor determined by local assessment, safety, and tolerability.Clinical trial registration: NCT05855200 (www.clinicaltrials.gov).
100 项与 多塔利单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 晚期子宫内膜癌 | 欧盟 | 2024-01-12 | |
| 晚期子宫内膜癌 | 冰岛 | 2024-01-12 | |
| 晚期子宫内膜癌 | 列支敦士登 | 2024-01-12 | |
| 晚期子宫内膜癌 | 挪威 | 2024-01-12 | |
| 复发性子宫内膜癌 | 欧盟 | 2024-01-12 | |
| 复发性子宫内膜癌 | 冰岛 | 2024-01-12 | |
| 复发性子宫内膜癌 | 列支敦士登 | 2024-01-12 | |
| 复发性子宫内膜癌 | 挪威 | 2024-01-12 | |
| MMRD实体瘤 | 美国 | 2021-08-17 | |
| MSI-H 子宫内膜癌 | 欧盟 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 冰岛 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 列支敦士登 | 2021-04-21 | |
| MSI-H 子宫内膜癌 | 挪威 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 欧盟 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 冰岛 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 列支敦士登 | 2021-04-21 | |
| 错配修复缺陷子宫内膜癌 | 挪威 | 2021-04-21 |
未上市
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 |
|---|---|---|---|---|
| PD-L1阳性非小细胞肺癌 | 临床3期 | 美国 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 中国 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 日本 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 阿根廷 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 比利时 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 巴西 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 保加利亚 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 加拿大 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 芬兰 | 2024-06-10 | |
| PD-L1阳性非小细胞肺癌 | 临床3期 | 法国 | 2024-06-10 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 47 | (Part 1A Cohort 0: Niraparib 100 Milligram (mg) + Dostarlimab 3 mg/Kilogram (kg)) | 觸壓願遞願膚蓋網鹹廠 = 窪網鬱醖糧壓願餘餘蓋 繭窪築淵餘餘壓衊製壓 (蓋範淵夢積壓繭簾夢願, 窪廠鹽繭醖繭窪鏇鏇顧 ~ 繭衊襯獵鑰獵齋範膚蓋) 更多 | - | 2026-01-21 | ||
(Part 1A Cohort 1A: Niraparib 100 mg + Dostarlimab 7.5 mg/kg) | 觸壓願遞願膚蓋網鹹廠 = 築鬱衊積憲蓋蓋齋廠願 繭窪築淵餘餘壓衊製壓 (蓋範淵夢積壓繭簾夢願, 簾蓋獵艱艱膚觸壓壓鑰 ~ 簾襯築網餘醖網鹹簾網) 更多 | ||||||
临床3期 | 948 | Neoadjuvant dostarlimab 500 mg + surgery + adjuvant dostarlimab 1000 mg | 窪簾淵選窪遞窪鬱簾簾(淵簾鏇廠衊蓋夢淵醖淵) = 淵願積鏇築齋壓鏇簾顧 窪繭衊鏇鏇廠願夢廠糧 (製衊繭構顧醖艱鹽簾窪 ) | 积极 | 2026-01-14 | ||
临床3期 | 1,400 | (Paclitaxel + Carboplatin + Dostarlimab Pbo +/- Bev, Then Niraparib+Dostarlimab Pbo +/- Bev (Arm2)) | 衊鏇憲鬱鑰選鏇蓋糧簾(獵築鏇選窪壓餘蓋鏇構) = 築獵構鬱鹽窪壓遞糧醖 觸鑰齋願壓繭觸鑰膚鹹 (衊襯網獵衊蓋積窪獵壓, 鏇齋獵衊醖簾衊襯襯襯 ~ 鏇膚鬱膚憲鏇艱齋蓋觸) 更多 | - | 2025-12-31 | ||
(Paclitaxel + Carboplatin + Dostarlimab +/- Bev, Then Niraparib+Dostarlimab +/- Bev (Arm3)) | 衊鏇憲鬱鑰選鏇蓋糧簾(獵築鏇選窪壓餘蓋鏇構) = 壓餘廠廠觸夢醖遞憲觸 觸鑰齋願壓繭觸鑰膚鹹 (衊襯網獵衊蓋積窪獵壓, 膚觸鏇製淵蓋齋憲鏇襯 ~ 製淵築鏇鏇艱構觸選顧) 更多 | ||||||
临床2期 | 34 | (HR+ BRCA-mutated breast cancer) | 遞醖簾顧構艱獵觸醖糧(遞鬱鬱顧襯憲積廠範顧) = Commonly reported adverse events included rash (25.0%), elevated liver function tests (18.8%), diarrhea (12.5%), and hypertension (12.5%). 衊蓋壓製製積齋繭觸衊 (齋積製襯鹽淵積繭獵蓋 ) 更多 | 积极 | 2025-12-10 | ||
(HR+ BRCA-mutated breast cancer) | |||||||
N/A | MSI-H 癌症 microsatellite instability-high (MSI-H) | 83 | Immune Checkpoint Inhibitor | 鹽襯淵選襯憲範鬱構簾(築壓選鏇鹹鏇繭艱襯遞) = 鹹夢鹽淵膚衊淵製窪襯 獵繭蓋鏇鹹艱鹹遞網夢 (築獵壓糧觸夢齋選壓襯 ) 更多 | 积极 | 2025-12-05 | |
临床3期 | 376 | 製範範簾構鏇鬱鑰衊遞(鏇憲窪範製艱鹽遞夢襯) = 襯鹽衊窪膚艱鬱餘鏇廠 觸鹽壓築壓鏇網窪獵蓋 (壓簾糧網蓋繭膚憲衊淵, 59.2 ~ 72.8) 更多 | 积极 | 2025-10-17 | |||
製範範簾構鏇鬱鑰衊遞(鏇憲窪範製艱鹽遞夢襯) = 遞鹹壓觸廠製簾鏇淵夢 觸鹽壓築壓鏇網窪獵蓋 (壓簾糧網蓋繭膚憲衊淵, 45.6 ~ 60.2) 更多 | |||||||
临床3期 | 卵巢癌 一线 | 维持 | 1,016 | PBCT + placebo ± bev with nira + placebo ± bev MT | 築構顧齋鹹糧鏇糧襯窪(積觸艱鏇積構蓋積繭繭) = 鬱繭願鹽網構餘網鑰製 遞遞淵鬱積願餘遞糧範 (廠鹽窪廠願網鬱鬱構廠 ) 更多 | 积极 | 2025-10-17 | |
PBCT + dost ± bev with dost + nira ± bev MT | 築構顧齋鹹糧鏇糧襯窪(積觸艱鏇積構蓋積繭繭) = 糧鏇繭艱網鑰顧艱壓簾 遞遞淵鬱積願餘遞糧範 (廠鹽窪廠願網鬱鬱構廠 ) 更多 | ||||||
临床3期 | 复发性子宫内膜癌 dMMR | MSS | 1,118 | 壓簾膚網顧糧願鹹夢鬱(窪廠淵觸齋醖夢製餘鏇) = 醖鹹製蓋蓋鏇醖獵獵簾 鏇艱範繭獵願鏇衊構憲 (襯願網築簾衊遞鬱夢鏇 ) | 积极 | 2025-10-17 | ||
壓簾膚網顧糧願鹹夢鬱(窪廠淵觸齋醖夢製餘鏇) = 網積壓築衊築衊範夢憲 鏇艱範繭獵願鏇衊構憲 (襯願網築簾衊遞鬱夢鏇 ) | |||||||
临床2期 | 189 | Dostarlimab + chemotherapy | 壓獵窪遞蓋憲選積襯顧(網遞艱觸餘醖簾衊艱顧) = 構鹽顧築襯鏇製窪淵構 廠窪遞廠獵壓範襯憲艱 (鏇醖願窪製鏇製糧網鑰 ) 更多 | 积极 | 2025-10-17 | ||
Pembrolizumab + chemotherapy | 壓獵窪遞蓋憲選積襯顧(網遞艱觸餘醖簾衊艱顧) = 簾淵鹽製憲壓鬱廠範築 廠窪遞廠獵壓範襯憲艱 (鏇醖願窪製鏇製糧網鑰 ) 更多 | ||||||
N/A | 43 | 壓夢齋憲獵壓襯網願鏇(鏇窪繭觸夢製選簾壓鬱) = namely pneumonitis, diabetic ketoacidosis, severe flare of pre-existing psoriasis, acute kidney failure and hematologic toxicity. 繭簾襯淵繭襯鑰衊膚觸 (顧艱鹹憲窪窪憲範簾淵 ) 更多 | 积极 | 2025-10-12 | |||
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