预约演示
更新于：2026-10-28
Calderasib
更新于：2026-10-28
概要
基本信息
药物类型 小分子化药 |
别名 MK 1084、MK-1084 |
作用方式 抑制剂 |
作用机制 KRAS G12C抑制剂(KRAS G12C突变抑制剂) |
在研适应症 |
非在研适应症- |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评突破性疗法 (中国) |
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结构/序列
分子式C32H31ClF2N6O4 |
InChIKeyBBIVCWWQPMOKAC-UHFFFAOYSA-N |
CAS号2641216-67-1 |
关联
19
项与 Calderasib 相关的临床试验NCT07554339
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
Researchers are looking for new ways to treat locally advanced non-small cell lung cancer (NSCLC) that is unresected and has a gene mutation called KRAS G12C. Researchers want to learn if calderasib (MK-1084) can be given with durvalumab, an immunotherapy, to treat NSCLC after chemotherapy and radiation therapy.
The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
The goal of this trial is to learn if participants who receive calderasib and durvalumab live longer without the cancer growing or spreading compared to participants who receive placebo and durvalumab.
开始日期2026-06-18 |
申办/合作机构 |
ChiCTR2600124257
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
开始日期2026-05-15 |
申办/合作机构- |
NCT07286149
KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
Researchers want to learn if MK-1084, the study medicine, can treat advanced or metastatic non-squamous NSCLC. MK-1084 is a targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread. The goals of this study are to learn:
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments
* About the safety of MK-1084 and if people tolerate it when taken with other treatments
* How many people have the cancer respond (get smaller or go away) to the treatments
开始日期2026-04-30 |
申办/合作机构 |
100 项与 Calderasib 相关的临床结果
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100 项与 Calderasib 相关的转化医学
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100 项与 Calderasib 相关的专利（医药）
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7
项与 Calderasib 相关的文献（医药）2026-05-28·CANCER INVESTIGATION
A Systematic Review of the Efficacy of KRAS p.G12C Inhibitors in Metastatic Colorectal Cancer: The Current State of Science
Review
作者: Baytar, Doga Kahramangil ; Boby, Jeffrey Mathew ; Benny, Jame Mathew ; Peniche, Paola Zinser ; Sahin, Ibrahim Halil ; Ilerhunmwuwa, Nosakhare
BACKGROUND:
KRAS p.G12C (c.34G > T) inhibitors have been reported to have varying survival outcomes in CRC patients across studies. Hence, our review aimed to provide a comprehensive understanding of the efficacy and safety of these agents among the CRC population.
METHODS:
Major databases, including but not limited to PubMed and Ovid, were searched for original clinical trials assessing the efficacy or safety of KRAS p.G12C (c.34G > T) inhibitors in CRC patients through May 2025. Studies with non-G12C KRAS-mutated populations were excluded. Data on patient demographics and various variables, including but not limited to OS, PFS, and TRAE incidence, were extracted from included studies.
RESULTS:
Our systematic review analyzed 18 trials and 1011 patients. Adagrasib monotherapy yielded a median PFS of 4.4-5.6 months, an OS of 10-19.8 months, and an ORR of 19-23%, while its combination with cetuximab reported a PFS of 6.9 months, an OS of 13.4-15.9 months and an ORR of 34-46%. Sotorasib monotherapy (960 mg) reported a PFS of 4 months, an OS of 10.6 months, and an ORR of 9.7. When combined with panitumumab, 960 mg sotorasib demonstrated better results with a PFS of 5.6-5.7 months, OS of 15.2 months and an ORR of 12.5-30%. Similarly, divarasib monotherapy led to a PFS of 5.6-6.9 months and an ORR of 20%, while its combination with cetuximab resulted in a PFS of 8.1 months and an ORR of 62.5%. Combination therapy of olomorasib and MK-1084, which are new-generation KRAS p.G12C (c.34G > T) inhibitors, with cetuximab also demonstrated highly promising efficacy with ORR of 38-44% and 50%, respectively. Olomorasib with cetuximab also showed a PFS of 6.6-7.5 months. Nausea, vomiting, diarrhea, rash, and increased AST/ALT were the most common TRAEs.
CONCLUSIONS:
Initial results of KRAS-G12C inhibitors appear highly promising when they are combined with anti-EGFR therapy compared to historical therapeutic agents indicated for patients with chemotherapy-refractory CRC. Encouraging benefits warrant frontline trials with these novel therapeutics.
2026-04-23·JOURNAL OF MEDICINAL CHEMISTRY
From KRAS
G12D
to Pan-KRAS Inhibitors─A Journey Enabled by Synthetic Innovation and Structure-Based Drug Design
Article
作者: Schopf, Patrick ; Lacey, Brian M. ; Day, Philip J. ; O’Reilly, Marc ; Sagara, Takeshi ; Duggal, Ruchia ; Sloman, David L. ; Edelstein, Emma ; Lyons, Thomas W. ; Hoover, Andrew ; Swaminathan, Uma ; Chessari, Gianni ; Otte, Ryan D. ; Stoeck, Alexander ; Shibata, Kazuaki ; Palani, Anandan ; Ye, Yingchun ; Bennett, D. Jonathan ; Kobayakawa, Yu ; Solban, Nicolas ; Su, Dan ; Han, Yongxin ; Miller, Richard ; Ma, Xiaoshen ; Venkataraman, Sriraman ; Howard, Steven ; Gathiaka, Symon ; Henderson, Timothy J. ; Sather, Aaron ; Shikata, Yuki ; Munsell, Erik V. ; Rees, David C. ; Oshima, Tsuyoshi ; Kawamura, Shuhei ; Mizuarai, Shinji ; Mansueto, My S.
KRAS, a significant oncology target, has been challenging to develop drugs for until recent discoveries of KRASG12C mutant-specific covalent inhibitors, including MK-1084. This article describes efforts toward the discovery of KRASG12D mutant-specific inhibitors and how synthetic innovations and structure-based drug design were utilized to facilitate the discovery of pan-KRAS inhibitors.
2026-01-23·ORGANIC LETTERS
Asymmetric Synthesis of KRAS G12C Inhibitor MK-1084 via a Crystallization-Induced Diastereomer Transformation (CIDT)
Article
作者: Kwan, Eugene E. ; Johnson, Heather C. ; Kong, Jongrock ; Wen, Xin ; Xu, Jing ; Nawrat, Christopher C. ; Chen, Yonggang ; Yuan, Yongpeng ; Shang, Gao ; He, Cyndi Qixin ; Belyk, Kevin M. ; Wan, Baoqiang ; Xiao, Kai-Jiong ; Hughes, Jonathan M. E. ; Song, Zhiguo J. ; Song, Zhiyan ; Li, Hongming ; Maddess, Matthew ; Sather, Aaron C. ; Zhang, Jin ; Yin, Jingjun ; Tan, Lushi ; Liu, Guiquan ; Fan, Chao ; Lam, Yu-hong
MK-1084 is a potent KRAS G12 inhibitor characterized by a complex macrocyclic ring system incorporating two atropisomeric axes from a restricted rotation around both C-C and N-C bonds. Herein, we report an efficient synthetic approach to manufacture MK-1084 to enable clinical trials. By leveraging the in-depth understanding of the inherent properties of axial chirality, we discovered and developed a one-pot crystallization-induced diastereomer transformation (CIDT)/carbonylation process to establish the unique and challenging macrocyclic core with double axial chiral centers from a racemic advanced precursor and readily available raw materials.
181
项与 Calderasib 相关的新闻（医药）2026-10-27
Every ESMO conference is eventful, but the drama kicked into gear earlier than expected this year when the eagerly anticipated phase 3 data for Moderna and Merck & Co.’s cancer vaccine were leaked two days before the Presidential Symposium.
Shweta Jain, vice president of global clinical development and oncology clinical research at Merck, acknowledged to Fierce in an interview that the leak was “unfortunate,” but explained that the Big Pharma and its partner had stuck to their plan on how to present the data on Saturday.
Going public with the headline data earlier than expected certainly didn’t deter delegates from queuing up for the Saturday symposium. As with previous ESMO show-stoppers, interest was so high that latecomers were reduced to standing around the sidelines of the cavernous Alicante Auditorium.
But it’s easy to assume that the slightly muted atmosphere during the presentation would have been more electric if the audience had been in genuine suspense about the data being unveiled.
Jain may have been resigned to the leak and wanted to focus attention on the trial's “convincing data,” but the ESMO organizers weren’t quite as relaxed. For this conference, Fierce—along with all journalists—was barred from entering either of the exhibition halls under a new policy preventing access to non-healthcare prescribers.
ESMO’s press office told Fierce they “understand your disappointment … and appreciate the frustration this has caused.” But they laid the blame on European legislation governing the promotion of medical products.
Biopharma executives who spoke to Fierce under the condition of anonymity speculated that this hard-line approach was, in fact, a knee-jerk reaction to the negative publicity surrounding the vaccine data leak.
For Merck’s Jain, the intismeran autogene readout was just the most high-profile announcement in a packed ESMO package from the Big Pharma that featured around seven oral presentations alongside “many, many, many abstracts and posters.”
That included two other presidential symposia to showcase Chinese phase 3 data for the Kelun-Biotech-partnered antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), as well as the potential for Keytruda to treat patients with a type of endometrial cancer.
Merck also reminded everyone that it has a contender in the hotly contested KRAS G12C inhibitor space by offering early data on how calderasib performed against solid tumors.
“I would say, put together, it just generally shows that we are working towards a more diverse portfolio,” Jain concluded.
At last year’s conference in Berlin , the general consensus was that next-gen ADCs were the stars of the show. But during Fierce’s conversations with senior executives from over 10 Big Pharmas and biotechs, as well as doctors and other attendees milling around the walkways of the sun-dappled IFEMA venue in outer Madrid, there was an altogether different vibe.
In fact, the overarching view was that this year’s theme was: there was no theme.
“I don't see a theme, right?” Incyte’s Global Head of R&D, Pablo Cagnoni, M.D., told Fierce in an impromptu interview in the empty ESMO press conference room.
With Incyte keen to pitch its KRAS G12D inhibitor INCB161734 as the only real rival to Revolution Medicine’s Rasonque follow-up zoldonrasib, Cagnoni acknowledged his focus at the conference had been on “a lot of KRAS stuff happening.”
Despite this tunnel vision, Cagnoni could still see the bigger picture.
“I walked into a couple of presentations randomly, and they were talking about applications of AI from anything from diagnosis to patient care-directed applications,” he said. “So I think that’s a big theme.”
“I think it’s impossible at this ESMO to not talk about the Moderna [cancer] vaccine,” he continued. “There’s strong passions on both sides—I happen to think the data are really good.”
“And the third point I would make is I was struck by the quality of the ovarian cancer readout from Genmab on Friday,” said Cagnoni, referencing the Danish biopharma’s phase 3 win for its Elahere rival Rina-S.
“A first analysis of a study showed survival hazard ratio 0.43,” he explained. “I think that is a really important data set for patients with ovarian cancer.”
Stefan Frings, M.D., Ph.D., deputy chief medical officer at Roche Pharma, had a similar take.
“I would expect that there’s not a single theme, but rather many attractive modalities,” he summarized of the current state of the oncology R&D space.
“We tailor … the target to the modality,” Frings explained. “Sometimes it can be an ADC, sometimes immunotherapy.”
“Sometimes combination targeted molecules like divarasib are still very attractive,” he said, namechecking Roche’s own KRAS G12C inhibitor that aced Amgen’s Lumakras and Bristol Myers Squibb’s Krazati in a phase 3 non-small cell lung cancer study.
“It showcases here that we are making progress in treating cancer,” he concluded.
For the duration of the conference, Roche set up shop in an elegant hotel a couple of miles away from IFEMA. The Swiss pharma weren’t the only ones to seek some calm away from the bustle of the ESMO crowds.
Next, Fierce headed to a Novotel a stone’s throw from the venue to catch up with Yusri Elsayed, M.D., Ph.D., global oncology therapeutic area head at Johnson & Johnson Innovation, to get his take.
J&J had some exciting early-stage data from the regulated induced proximity targeting chimera (RIPTAC) platform acquired in its Halda Therapeutics buyout last year. But Elsayed was similarly open-minded about the most exciting mechanisms on display at this year’s ESMO.
“We are very excited about the RIPTAC, of course,” he said. “But we are also very excited about ways of trying to reach patients, minimizing toxicities and increasing efficacy.”
“For example, we are working now on degrader-antibody conjugates ,” he said, alluding to a platform J&J picked up in its Firefly Bio acquisition in June. “You don't hear about it a lot, but definitely for next ESMO.”
Elsayed and his team were also “excited to hear about” Merck and Moderna’s vaccine success, he pointed out.
As to the reduced emphasis on ADCs this year, “I don't think that’s a bad thing,” he said.
“The emergence of new mechanisms of action, I think, is very exciting.”
That’s not to say that ADCs were kept a low profile at this year’s ESMO. As well as Merck's sac-TMT, GSK unveiled fresh phase 1 data from its Hansoh-partnered B7-H4-directed mo-rez, while AstraZeneca insisted to Fierce that the mixed phase 3 gastric cancer data for its Claudin18.2-targeting sono-ve will be enough to win over regulators.
Takeda used ESMO to lift the lid on its own late-stage success for a CLDN18.2 ADC, called arcotatug tavatecan. As far as P.K. Morrow, M.D., head of Takeda’s oncology therapeutic area unit, was concerned, the modality still has plenty to offer.
“What you saw here—not just with this, but other data across ESMO—is how do we continue to optimize the tolerability profile so we can deliver the degree of efficacy to patients,” she told Fierce.
“So ADCs really are here to stay,” she added.
The most exciting areas of biopharma R&D is among the hot topics being discussed at Fierce Biotech's high-impact event in London next month. Find out more information and register by clicking on the banner below:
临床3期疫苗临床结果免疫疗法抗体药物偶联物
2026-10-21
默沙东将在2026 ESMO大会展示在研肿瘤管线III期关键研究首次结果及现有产品组合的持续创新潜力
INTerpath-001研究结果将于主席专题研讨会（Presidential Symposium）公布，首次发布在研个体化新抗原疗法intismeran autogene联合帕博利珠单抗的III期研究数据
芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）TroFuse-005研究数据将于主席专题研讨会公布
KEYNOTE-C93研究数据将于主席专题研讨会公布，进一步探索帕博利珠单抗单药一线治疗在错配修复缺陷（dMMR）的晚期或复发性子宫内膜癌患者中的重要作用
美国新泽西州罗威市，2026年10月13日——默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号）宣布公司三项关键性临床研究的首次结果将于2026年欧洲肿瘤内科学会（ESMO）大会期间的最新突破性研究主席专题研讨会（Late-Breaking Presidential Symposia）公布。大会将于10月23日至27日在西班牙马德里举行。此外，公司还将在本次大会期间发布来自20余种肿瘤类型、覆盖肿瘤产品组合及研发管线的90余项摘要研究成果。
Marjorie Green博士
默沙东实验室高级副总裁
肿瘤学全球临床开发负责人
“
本届ESMO大会公布的新数据，包括来自三项关键性研究的主席专题研讨会报告，彰显了默沙东业界领先的肿瘤产品组合及研发管线的广度与深度。我们很高兴首次分享intismeran[1]和芦康沙妥珠单抗[2]的III期研究结果，并同步展示来自公司肿瘤产品组合的最新研究进展，这进一步体现了我们致力于推动多种癌症领域创新研究的坚定承诺。
”
将在ESMO大会公布的默沙东产品组合及在研管线关键数据包括：
III期INTerpath-001研究首次数据发布。该研究评估在研个体化新抗原疗法intismeran autogene（intismeran；V940/mRNA-4157）联合帕博利珠单抗用于完全切除后的IIB-IV期黑色素瘤患者辅助治疗。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA1，主席专题研讨会I）[3]。
III期TroFuse-005研究首次数据发布。该研究评估在研TROP2靶向抗体偶联药物（ADC）芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）用于既往接受含铂化疗以及程序性死亡受体-1（PD-1）抑制剂或程序性死亡配体-1（PD-L1）抑制剂治疗后发生疾病进展的晚期或复发性子宫内膜癌患者。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA11，主席专题研讨会III）[4],[5]。
III期KEYNOTE-C93研究首次数据发布。该研究评估帕博利珠单抗[6]单药一线治疗既往未接受过系统性化疗或在接受辅助治疗后出现疾病复发的错配修复缺陷（dMMR）晚期或复发性子宫内膜癌患者的疗效。相关结果将入选ESMO主席专题研讨会（摘要编号#LBA12，主席专题研讨会III）[5]。
III期OptiTROP系列研究数据发布，评估芦康沙妥珠单抗（sacituzumab tirumotecan，sac-TMT）在非小细胞肺癌（NSCLC）中的应用，包括OptiTROP-Lung06研究（摘要编号#LBA66）在一线PD-L1阴性晚期非鳞状NSCLC患者中的研究结果；以及OptiTROP-Lung04研究（摘要编号#LBA67）在EGFR酪氨酸激酶抑制剂（TKI）治疗进展后EGFR突变NSCLC患者中的最终总生存期（OS）结果（口头报告专场1：转移性NSCLC）[7]。
III期LITESPARK-011研究最终分析结果发布。该研究评估贝组替凡[8]，默沙东首创口服缺氧诱导因子-2α（HIF-2α）抑制剂，与仑伐替尼[9]联合用于接受PD-1抑制剂或PD-L1抑制剂治疗后、伴透明细胞成分的晚期肾细胞癌患者的疗效。仑伐替尼是卫材研发的一种口服多靶点TKI药物（摘要编号#3587O，口头报告专场2：泌尿系统肿瘤-肾癌及尿路上皮癌）[10]。
默沙东投资者活动：
默沙东将在ESMO大会期间，于10月26日晚上7:30（欧洲中部时间）举办肿瘤业务投资者活动，分享公司肿瘤战略及项目进展。活动将在西班牙马德里举行，并同步线上播出。投资者、分析师、媒体以及公众可点击文章下方“阅读原文”访问活动。
上述摘要及默沙东其他重点摘要的详细信息：
乳腺肿瘤
Final OS analysis of sacituzumab tirumotecan versus chemotherapy in previously treated locally recurrent or metastatic triple-negative breast cancer: Phase III OptiTROP-Breast01. M. Li.[7]
Presentation #4639RO, Rapid oral session 2: Breast cancer, advanced stage
Results from KEYNOTE-B49: A Phase 3, randomized, double-blind study of pembrolizumab (pembro) vs placebo (pbo) plus chemotherapy (CT) in participants (pts) with HR+/HER2− advanced breast cancer (ABC). H. S. Rugo.
Presentation #LBA51, Proffered paper session 2: Breast cancer, early and advanced stage
Association between disease control and patient-reported functioning and quality of life in the ASCENT-04/KEYNOTE-D19 study. K. Kalinsky.[11]
Presentation #4659P, Poster session: Triple negative breast cancer
消化道肿瘤
Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: Results from a Phase I study. D. J. Pinato.[3]
Presentation #3151P, Poster session: Pancreatic cancer
泌尿系统肿瘤
Final analysis of the Phase 3 LITESPARK-011 study: Belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti-PD-(L)1 therapy. D. Y. Heng.[10]
Presentation #3587O, Proffered paper session 2: Genitourinary tumours, renal and urothelial
Final protocol-prespecified analysis of the Phase 3 KEYNOTE-564 trial of adjuvant pembrolizumab versus placebo in clear cell renal cell carcinoma (ccRCC). T. K. Choueiri.
Presentation #3589RO, Rapid oral session 2: Genitourinary tumours, renal and urothelial
Enfortumab vedotin (EV) with or without pembrolizumab (P) as first-line (1L) treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma (la/mUC): Long-term follow-up analysis from EV-103 cohorts DE/A and K. J. P. Maroto Rey.[12]
Presentation #4740RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial
ctDNA analysis of the Phase 3 KEYNOTE-B15 trial: Neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) + pembrolizumab (pembro) for participants (pts) with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin. J. A. Chatzkel.[12]
Presentation #4734O, Proffered paper session 1: Genitourinary tumour, renal and urothelial
Health-related quality of life (HRQoL) with neoadjuvant and adjuvant (neoadj-adj) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) eligible for cisplatin in the Phase 3 KEYNOTE-B15 study. A. Gomez de Liano Lista.[12]
Presentation #4738RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial
Perioperative pembrolizumab (pembro) or enfortumab vedotin (EV) plus pembro in pts with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: Ad hoc analysis from KEYNOTE-905. A. Ullén.[12]
Presentation #4733O, Proffered paper session 1: Genitourinary tumour, renal and urothelial
Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for locally advanced or metastatic urothelial carcinoma (la/mUC): Results from a Phase 2 Study (2870-002/SKB264-II-06). X. Bian.[7]
Presentation #4739RO, Rapid oral session 1: Genitourinary tumours, renal and urothelial
Updated results from the Phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC). G. von Amsberg.
Presentation #2217RO, Rapid oral session: Genitourinary tumours, prostate, penile and testis
妇科肿瘤
Sacituzumab tirumotecan in previously treated advanced or recurrent endometrial cancer: Results from the Phase 3 TroFuse-005/ENGOT-en23/GOG-3095 study. D. Lorusso.[4],[5]
Presentation #LBA11, Proffered paper session: Presidential Symposium III
KEYNOTE-C93/GOG-3064/ENGOT-en15: Phase 3, randomized, open-label study of first-line (1L) pembrolizumab (pembro) vs carboplatin (C) + paclitaxel (P) in mismatch repair-deficient (dMMR) advanced or recurrent endometrial carcinoma (a/rEC). B. M. Slomovitz.[5]
Presentation #LBA12, Proffered paper session: Presidential Symposium III
Raludotatug deruxtecan (R-DXd) + bevacizumab (bev) in participants (pts) with platinum-resistant recurrent ovarian cancer (PROC): Results for cohort B-1 of the Phase 1b/2 REJOICE-Ovarian02 study. A. Oaknin.[13]
Presentation #1247RO, Rapid oral session 2: Gynaecological cancers
Raludotatug deruxtecan (R-DXd) in patients (pts) with platinum-resistant ovarian cancer (PROC): An updated analysis of efficacy and tolerability from the Ph 2 part of REJOICE-Ovarian01. K. Hasegawa.[13]
Presentation #1331P, Poster session: Gynaecological cancers
NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer. F. Backes.[14]
Presentation #1239O, Proffered paper session: Gynaecological cancers
Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC): Results from a Phase 2 study (2870-002/SKB264-II-06). L. Chen.[7]
Presentation #1259P, Poster session: Gynaecological cancers
头颈肿瘤
Practical considerations for adopting perioperative pembrolizumab in locally advanced head and neck squamous cell carcinoma (LA HNSCC) in Europe: Insights from KEYNOTE-689. M. Oliva.
Presentation #1580P, Poster session: Head and neck cancer, excluding thyroid
肺癌
Sacituzumab tirumotecan (sac-TMT) plus pembrolizumab (P) versus chemotherapy (chemo) plus pembrolizumab (P) as first-line (1L) treatment for PD-L1 negative advanced non-squamous (nsq) NSCLC: Randomized Phase 3 OptiTROP-Lung06 study. C. Zhou.[7]
Presentation #LBA66, Proffered paper session 1: NSCLC, metastatic
Final OS analysis of sacituzumab tirumotecan (sac-TMT) versus platinum-based chemotherapy in EGFR-mutated non-small cell lung cancer (NSCLC) after progression on EGFR-TKI: Phase III OptiTROP-Lung04 study. W.F. Fang. [7]
Presentation #LBA67, Proffered paper session 1: NSCLC, metastatic
Calderasib (MK-1084), alone or in combination, for KRAS G12C-mutant metastatic non-small cell lung cancer (mNSCLC). M. A. N. Sendur.[15]
Presentation #2680RO, Rapid oral session 2: NSCLC, metastatic
Final analysis of adjuvant pembrolizumab (pembro) in resected early-stage non–small-cell lung cancer (NSCLC): Phase 3 PEARLS/KEYNOTE-091 study. M. E. O’Brien.
Presentation #2511O, Proffered paper session: Non-metastatic NSCLC and other thoracic malignancies
Ifinatamab deruxtecan (I-DXd) in extensive-stage small cell lung cancer (ES-SCLC): IDeate-Lung01 updated results. M. Ahn.[13]
Presentation #3842P, Poster session: SCLC
黑色素瘤
INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma (MEL). G. V. Long.[3]
Presentation #LBA1, Proffered paper session: Presidential Symposium I
STARBOARD Phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini) and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma. D. Schadendorf.[12]
Presentation #2071O, Proffered paper session: Melanoma and other skin tumours
Physician perspectives on defining cure in early-stage melanoma. H. M. Shaw.
Presentation #2173eP, ePoster session: Melanoma
Patritumab deruxtecan (HER3-DXd) in melanoma after anti-PD-(L)1 therapy: Primary analysis from HERTHENA-PanTumor01. M. McKean.[13]
Presentation #2073RO, Rapid oral session: Melanoma and other skin tumours
跨瘤种
Final results of the TUXEDO-3 Phase II trial of patritumab deruxtecan (HER3-DXd) in active brain metastases (BMs) and leptomeningeal disease (LMD). M. Preusser.[13]
Presentation #690O, Proffered paper session: CNS tumours
Calderasib monotherapy in various KRAS G12C-mutated advanced solid tumors: Results from the Phase 1 KANDLELIT-001 study. M Kwiatkowski.[15]
Presentation #1039P, Poster session: Developmental therapeutics
[1] 截至目前，intismeran autogene尚未获国家药品监督管理局（NMPA）批准
[2] 芦康沙妥珠单抗（sac-TMT）上市许可持有人为四川科伦博泰生物医药股份有限公司
[3] 与莫德纳合作
[4] 与科伦博泰合作
[5] 与欧洲妇科肿瘤试验网络（European Network for Gynaecological Oncology Trial, ENGOT）各研究组及GOG Foundation, Inc.（GOG）合作
[6] 截至目前，国家药品监督管理局（NMPA）批准帕博利珠单抗注射液下列适应症，除此以外其他适应症尚未获批：
· 帕博利珠单抗适用于不可切除或转移性黑色素瘤的治疗。
· 帕博利珠单抗适用于由国家药品监督管理局批准的检测评估为PD-L1肿瘤比例分数（TPS）≥1%的表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的局部晚期或转移性非小细胞肺癌一线单药治疗。
· 帕博利珠单抗联合培美曲塞和铂类化疗适用于表皮生长因子受体（EGFR）基因突变阴性和间变性淋巴瘤激酶（ALK）阴性的转移性非鳞状非小细胞肺癌（NSCLC）的一线治疗。
· 帕博利珠单抗联合卡铂和紫杉醇适用于转移性鳞状非小细胞肺癌（NSCLC）患者的一线治疗。
· 帕博利珠单抗联合含铂化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于可手术切除的II、IIIA和IIIB期非小细胞肺癌患者。
· 帕博利珠单抗联合铂类和氟尿嘧啶类化疗药物用于局部晚期不可切除或转移性食管或胃食管结合部癌患者的一线治疗。
· 帕博利珠单抗单药用于由国家药品监督管理局批准的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥10）的、既往一线全身治疗失败的、局部晚期或转移性食管鳞状细胞癌（ESCC）患者的治疗。
· 帕博利珠单抗单药用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的转移性或不可切除的复发性头颈部鳞状细胞癌（HNSCC）患者的一线治疗。
· 帕博利珠单抗用于通过充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的可手术切除的局部晚期头颈部鳞状细胞癌成人患者，单药新辅助治疗，并在手术后联合放疗加或不加顺铂化疗进行辅助治疗，随后继续帕博利珠单抗单药治疗。
· 帕博利珠单抗单药用于KRAS、NRAS和BRAF基因均为野生型，不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）结直肠癌（CRC）患者的一线治疗。
· 帕博利珠单抗和仑伐替尼联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。
· 帕博利珠单抗单药用于既往接受过索拉非尼或含奥沙利铂化疗的HCC患者的治疗。
· 帕博利珠单抗联合吉西他滨和顺铂用于局部晚期或转移性胆道癌（BTC）患者的一线治疗。
· 帕博利珠单抗联合化疗新辅助治疗并在手术后继续帕博利珠单抗单药辅助治疗，用于早期高危三阴性乳腺癌(TNBC)患者的治疗。
· 帕博利珠单抗单药用于不可切除或转移性微卫星高度不稳定型（MSI-H）或错配修复基因缺陷型（dMMR）成人晚期实体瘤患者
o既往接受过氟尿嘧啶类、奥沙利铂和伊立替康治疗后疾病进展的结直肠癌患者；
o既往治疗后疾病进展且无满意替代治疗方案的其他实体瘤。
· 帕博利珠单抗联合含氟尿嘧啶类和铂类药物化疗用于局部晚期不可切除或转移性HER2阴性胃或胃食管结合部腺癌患者的一线治疗。
· 帕博利珠单抗联合曲妥珠单抗、含氟尿嘧啶类和铂类药物化疗，用于经充分验证的检测评估肿瘤表达PD-L1（综合阳性评分（CPS）≥1）的局部晚期不可切除或转移性HER2阳性胃或胃食管结合部腺癌患者的一线治疗。
· 帕博利珠单抗联合放化疗（CRT）用于国际妇产科联盟（FIGO）2014 III-IVA期宫颈癌患者的治疗。
· 帕博利珠单抗联合注射用维恩妥尤单抗用于局部晚期或转移性尿路上皮癌成人患者。
· 帕博利珠单抗联合卡铂和紫杉醇用于错配修复缺陷（dMMR）的原发晚期或复发性子宫内膜癌成人患者的一线治疗，随后以帕博利珠单抗单药维持治疗。
·帕博利珠单抗联合紫杉醇（联合或不联合贝伐珠单抗）用于经充分验证的检测评估肿瘤表达 PD-L1（综合阳性评分（CPS）≥1）的既往接受过一线或二线全身治疗的铂耐药上皮性卵巢癌、输卵管癌或原发性腹膜癌成人患者的治疗。
[7] 由科伦博泰主导，在中国开展
[8] 截至目前，国家药品监督管理局（NMPA）批准贝组替凡下列适应症，除此以外其他适应症尚未获批：
适用于治疗不需要立即手术治疗的 von Hippel-Lindau（VHL）病相关肾细胞癌（RCC）、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET）成人患者。
[9] 截至目前，国家药品监督管理局（NMPA）批准仑伐替尼下列适应症，除此以外其他适应症尚未获批：
· 仑伐替尼和帕博利珠单抗联合经动脉化疗栓塞（TACE），用于治疗不可切除的非转移性肝细胞癌（HCC）患者。
· 仑伐替尼单药适用于既往未接受过全身系统治疗的不可切除的肝细胞癌患者。
· 仑伐替尼适用于进展性、局部晚期或转移性放射性碘难治性分化型甲状腺癌患者。
[10] 与卫材合作
[11] 与吉利德科学合作
[12] 与安斯泰来/辉瑞合作
[13] 与第一三共合作
[14] 由美国国家癌症研究所（NCI）资助 /由NRG Oncology牵头开展
[15] 与大鹏药品工业株式会社（Taiho Pharmaceutical Co., Ltd.）及Astex Pharmaceuticals（UK）（大塚制药株式会社全资子公司）合作开展
若您想了解更多有关疾病知识的信息，请咨询医疗卫生专业人士
11-2026-CN-KEY-26079
关于默沙东
在默沙东（默沙东是美国新泽西州罗威市默克公司的公司商号），我们齐心协力追求共同的目标：我们发挥前沿科学的力量，在全球范围内拯救生命、改善生活。130多年来，我们通过研发重要药物和疫苗，为全人类带来希望。我们致力成为顶尖的研究密集型生物制药公司——当下，我们正处于研发前线，推出创新解决方案，以推进人类和动物疾病的预防和治疗。我们建立了一个多元、包容的全球员工体系，以负责的态度经营每一天，确保所有人、所有社区都能有一个安全、可持续和健康的未来。更多信息，请访问www.msd.com，并在X（前身为Twitter）、LinkedIn和Youtube平台关注我们。
关于默沙东中国
中国是默沙东全球增长战略中至关重要的一部分。默沙东中国总部设在上海，同时在北京设有研发中心、在杭州、宁波和天津分别设有工厂，实现了研发、制造和商业运营三擎合一。我们全心全意，向中国大众提供高质量的创新药物、疫苗和服务，造福中国社会。更多信息，敬请访问默沙东中国官网，或关注默沙东中国在微信上的官方社交媒体账号。
默沙东前瞻性声明
默沙东是美国新泽西州罗威市默克公司的公司商号（下称“公司”）。本新闻稿包含根据《1995 年美国私人证券诉讼改革法案》之安全条款而做出的“前瞻性声明”。本文内容基于公司管理层当前的看法和预期，并且受制于可能出现的重大风险和不确定因素。默沙东不保证在研产品能获得所需的监管部门批准或取得商业成功。如果相关假设与现实有所出入、出现风险，或发生不确定情况，实际结果可与前瞻性声明中的预期有实质上的差异。
风险和不确定因素包括但不仅限于一般行业情况与竞争、一般经济因素（包括利率与汇率浮动）、美国及其他国家制药行业监管以及医疗政策的影响、全球范围内控制医疗成本的趋势、技术发展、竞争对手获得的新产品与专利、新产品开发固有的挑战（包括获得监管部门批准）、默沙东对未来市场形势做出准确预测的能力、生产上的困难或迟延、国际经济金融状况不稳定与主权风险、对默沙东专利和其它创新产品保护的有效性的依赖程度，以及公司面临专利诉讼和/或监管行动的风险。
默沙东没有义务就新信息、未来事件或其它原因对任何前瞻性声明进行公开的更新。尚有其它因素可能导致实际结果与前瞻性声明存在实质性差异，请参见默沙东2025年年报10-K报表以及公司在美国证券交易所备案的其它文件（可在美国证券交易所网站www.sec.gov上查阅）。
2026-10-14
2026-10-15要点提炼
临床前资产以4亿美元首付款定价。思璞锐将口服KRAS G12D（ON）抑制剂SPR2015的全球开发、生产及商业化权利独家授予默沙东，获4亿美元首付款，交易潜在总价值最高21.3亿美元，后续里程碑上限17.3亿美元，交易已完成交割［1］。定价依据是靶点价值与分子设计差异化，而非已验证的临床疗效。
“分子胶＋共价”的活化态路线已被同类分子独立验证，但G12D成药门槛高。SPR2015与亲环素A（CypA）及KRAS G12D形成三元复合物并共价结合［2］；同类研究以CypA构建新形态蛋白界面，实现对G12D天冬氨酸的酶样速率增强共价抑制，获得口服可及的zoldonrasib（RMC-9805）［3］。天冬氨酸亲核性低、羧酸在蛋白质组中丰度高，是该路线的化学障碍［3］。
G12D赛道已进入III期竞争，价值兑现取决于人体暴露与耐药应对。zoldonrasib、setidegrasib（ASP3082）、GFH375等已进入III期，首个进入临床的非共价抑制剂MRTX1133因制剂问题终止［6］；默沙东以calderasib推进KRAS G12C的KANDLELIT系列III期研究［6］，SPR2015用于补齐其G12D缺口。一、交易结构：4亿美元首付款与17.3亿美元的后续空间
2026年9月28日，上海思璞锐医药科技有限公司与默沙东（MSD）宣布，就临床前口服KRAS G12D（ON）抑制剂SPR2015达成全球独家授权协议：默沙东获得该分子全球开发、生产及商业化的独家权利，思璞锐获得4亿美元首付款，并有资格获得与多个适应症相关的开发、商业化及其他活动有关的里程碑付款，包括首付款在内交易潜在总价值最高21.3亿美元，交易已完成交割［1］。以潜在总额扣除首付款计算，后续付款上限为17.3亿美元，实际支付取决于约定里程碑的实现；公告未列出逐项里程碑金额、触发条件或销售提成安排［1］。二、靶点与分子设计：G12D难在哪里
G12D指KRAS第12位氨基酸由甘氨酸变为天冬氨酸，使促生长信号持续活跃［1］，它是人类肿瘤中最常见的致癌性RAS突变［1］，在胰腺导管腺癌中KRAS突变见于90%以上患者且以G12D最常见［5］。其难点在于天冬氨酸亲核性低、羧酸在蛋白质组中丰度高，难以选择性共价靶向，因而长期被视为“不可成药”［3］。SPR2015采用分子胶型设计，“ON”对应KRAS的活化状态：AACR 2026摘要报告其与CypA及KRAS G12D形成三元复合物并共价结合，并观察到较持久的CypA结合与靶点占有［2］。该范式已有独立验证，以CypA在CypA与活化态RAS之间构建新形态界面，可使天冬氨酸与低反应性亲电弹头发生酶样速率增强的共价反应，并产出具有口服生物利用度的zoldonrasib［3］。范式获得验证，但SPR2015仍须在临床回答：能否在可耐受暴露下实现充分而持续的靶点抑制。三、临床前证据与尚未回答的问题
AACR 2026第5978号摘要显示，在胰腺导管腺癌和非小细胞肺癌小鼠异种移植模型中，SPR2015每日一次口服10 mg/kg可抑制肿瘤生长，30 mg/kg可见肿瘤缩小；研究还在超过15种结直肠癌CDX/PDX模型中评价了其单药活性［2］。交易公告补充，其在多种KRAS G12D突变细胞系中显示纳摩尔级增殖抑制活性，并对KRAS野生型保持良好选择性［1］。上述剂量与疗效均来自小鼠，人体可耐受剂量、药物暴露、客观缓解率及缓解持续时间仍待临床试验确定［1,2］。同类分子也提示组合治疗的必要性：MRTX1133的KD约0.2 pM，对G12D的选择性约为野生型的700倍，中位细胞IC50约5 nM，在11个胰腺导管腺癌模型中8个（73%）实现≥30%的肿瘤消退［4］。四、默沙东的布局逻辑：G12C已至III期，G12D需要补位
默沙东在KRAS方向已有布局。公开登记信息显示，其口服KRAS G12C抑制剂calderasib（MK-1084）的KANDLELIT系列包含多项III期研究：KANDLELIT-007（NCT07190248）计划入组675例，评价MK-1084联合皮下注射帕博利珠单抗复方制剂对比含铂化疗的一线治疗；KANDLELIT-004（NCT06345729）在PD-L1 TPS≥50%人群中评估MK-1084联合帕博利珠单抗，计划入组600例；KANDLELIT-012（NCT06997497）覆盖一线KRAS G12C突变晚期结直肠癌，计划入组477例［6］。默沙东研究实验室负责药物发现、临床前开发及转化医学的高级副总裁George Addona在公告中称，此次合作将SPR2015这一针对人类癌症最常见KRAS突变类型之一的强效工程化抑制剂纳入研发管线［1］。G12C经验可支撑研发组织与试验实施，但SPR2015在G12D肿瘤中的作用仍需自身临床数据建立；公告未披露首个人体研究方案或联合治疗计划［1］。五、授权方的资本与管线背景
思璞锐创立于2024年底，总部位于上海，由胡滔博士与张杨博士共同创立，专注小分子抗肿瘤药物；胡滔曾任职于默沙东、安进及药明康德，张杨曾任药明康德国内新药研发服务部副总裁［1］。公司于2025年6月完成超2亿元人民币天使轮融资（博远资本、汉康资本联合领投），2026年1月完成超3500万美元Pre-A轮融资（弘晖基金领投，InnoPinnacle Fund跟投），两轮合计6500万美元，用于加速核心管线SPR1020的临床开发和推进新一代分子胶型RAS抑制剂的IND工作［1］。其高选择性PARP1抑制剂SPR1020已于2026年1月完成首例受试者给药，首次人体I/II期研究登记号为NCT07359066［1］。六、竞争格局与主要风险
G12D已从“不可成药”议题变为密集竞争的赛道：公开登记信息中相关注册研究已近百项，zoldonrasib已启动一线胰腺癌（NCT07621718）与非小细胞肺癌（NCT07777822）III期研究，并开展与daraxonrasib联合的III期研究（NCT07805954）；setidegrasib（ASP3082）开展对照多西他赛的III期研究（NCT07566052）；GFH375、INCB161734等亦进入III期。与此同时，首个进入临床的非共价抑制剂MRTX1133的I期研究（NCT05737706）因制剂问题终止［6］，说明口服暴露与制剂工艺是实际门槛。耐药是共同挑战：对daraxonrasib获得性耐药的分析显示，44例配对循环肿瘤DNA中59%出现RAS通路治疗期间新发改变，其中KRAS扩增占36%、MAPK通路占25%、RTK与PI3K各占9%，未见继发性KRAS突变，提示需联合DNA损伤修复药物、RTK抑制剂或G12D抑制剂［7］。七、结论
对默沙东而言，这是在G12C资产推进III期的同时，以4亿美元首付款锁定一张G12D入场券；对思璞锐而言，公司价值与一个尚未进入人体的分子紧密绑定［1］。关键在于能否在人体达到具有药理活性的暴露、能否形成可持续的抗肿瘤作用，以及在胰腺癌、结直肠癌和肺癌中如何体现［1,2］。参考文献
［1］上海思璞锐医药科技有限公司（SciBrunch Therapeutics）. 公司新闻：思璞锐与默沙东就在研口服KRAS G12D（ON）抑制剂SPR2015达成全球独家授权协议（2026-09-28）；思璞锐完成超2亿元天使轮融资，专注小分子抗肿瘤创新药开发（2025-06-05）；首例患者入组！思璞锐启动高选择性PARP1抑制剂SPR1020临床I期试验（2026-01-09）；思璞锐SciBrunch完成超3500万美元Pre-A轮融资，近期两轮融资合计6500万美元（2026-01-30）. 检索日期：2026-09-29. https://scibrunch.com/zh/news/6；https://scibrunch.com/zh/news/1/；https://scibrunch.com/zh/news/3/；https://scibrunch.com/zh/news/4/
［2］Qian Y, Zhang Z, Fu Z, et al. Abstract 5978: SPR2015, a highly potent and selective KRAS G12D (on) inhibitor, exhibits favorable pharmacokinetic behavior and significant anti-tumor efficacy against colorectal cancer as monotherapy in preclinical models. Cancer Res. 2026;86(7 Suppl):5978. doi:10.1158/1538-7445.AM2026-5978
［3］Weller C, Burnett GL, Jiang L, et al. A neomorphic protein interface catalyzes covalent inhibition of RAS(G12D) aspartic acid in tumors. Science. 2025;389(6758):eads0239. doi:10.1126/science.ads0239
［4］Hallin J, Bowcut V, Calinisan A, et al. Anti-tumor efficacy of a potent and selective non-covalent KRAS(G12D) inhibitor. Nat Med. 2022;28(10):2171-2182. doi:10.1038/s41591-022-02007-7
［5］Kemp SB, Cheng N, Markosyan N, et al. Efficacy of a small-molecule inhibitor of KrasG12D in immunocompetent models of pancreatic cancer. Cancer Discov. 2023;13(2):298-311. doi:10.1158/2159-8290.CD-22-1066
［6］ClinicalTrials.gov. KANDLELIT-007（NCT07190248）、KANDLELIT-004（NCT06345729）、KANDLELIT-012（NCT06997497）；zoldonrasib（RMC-9805）I期（NCT06040541）与III期（NCT07621718、NCT07777822、NCT07805954）；setidegrasib（ASP3082）III期（NCT07566052）；MRTX1133 I期（NCT05737706，已终止）；SPR1020 I/II期（NCT07359066）. 检索日期：2026-09-29. https://clinicaltrials.gov
［7］Aronchik I, Kar S, Zhuang Y, et al. Acquired resistance to the RAS(ON) multi-selective inhibitor daraxonrasib guides rational combination therapy strategies in pancreatic cancer. Nat Med. 2026;32(8):2865-2877. doi:10.1038/s41591-026-04537-w
100 项与 Calderasib 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局部晚期非小细胞肺癌 | 临床3期 | 美国 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 美国 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 美国 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 日本 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 日本 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 日本 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2026-06-18 | |
| 局部晚期非小细胞肺癌 | 临床3期 | 澳大利亚 | 2026-06-18 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床1期 | KRAS G12C突变非小细胞肺癌 KRAS G12C | 193 | 觸構淵繭獵獵製醖夢鹹(鹽衊網衊觸鏇選願憲壓) = 獵選壓艱製鑰鏇艱構鏇 簾衊築積簾網鹹憲衊壓 (蓋醖製憲壓蓋窪網鹹構, 58 ~ 82) 更多 | 积极 | 2026-10-23 | ||
觸構淵繭獵獵製醖夢鹹(鹽衊網衊觸鏇選願憲壓) = 網選範繭選餘膚築繭鬱 簾衊築積簾網鹹憲衊壓 (蓋醖製憲壓蓋窪網鹹構, 88 ~ 98) 更多 | |||||||
临床1期 | KRAS G12C突变的实体瘤 KRAS G12C mutation | 60 | 夢鹹願餘艱築淵襯鏇夢(繭醖醖衊願夢獵齋衊鑰) = 鑰窪壓構願艱鑰遞艱獵 淵憲窪積蓋遞鏇蓋築蓋 (選夢遞襯醖鑰鹹鹹餘繭, 18 ~ 43) 更多 | 积极 | 2026-10-23 | ||
临床1/2期 | 190 | 鬱鑰鬱鏇憲壓構鬱廠簾(繭壓衊鏇艱鹹積襯衊蓋) = 夢襯鬱醖繭夢簾壓鬱觸 範鹹繭顧願醖繭製網鏇 (製淵積選鑰膚築齋選鬱, 4.4 ~ 8.3) 更多 | 积极 | 2026-09-12 | |||
Calderasib + sac-TMT | 鑰艱廠鑰範餘獵觸構選(齋選願醖鏇築鬱淵鹽夢) = 鹽鏇構遞獵觸壓鹹獵製 鏇淵醖廠簾網獵衊膚窪 (積齋鹹淵艱憲簾壓蓋簾 ) 更多 | ||||||
临床3期 | 400 | Calderasib+pembrolizumab SC | 餘構願齋艱構繭膚淵繭(憲顧積餘廠獵醖鹽憲憲) = 積鬱憲獵憲糧衊積鏇夢 衊顧積夢獵願遞獵築鬱 (鏇鹽鑰淵顧簾夢夢壓網, 85 ~ 93) 更多 | 积极 | 2026-09-12 | ||
Placebo + pembrolizumab SC | 襯窪鑰憲願糧糧淵鹽襯(窪遞衊衊窪鬱範鏇鑰願) = 簾窪鑰鹹鏇糧夢遞醖蓋 築襯鹽鏇憲網艱廠觸蓋 (網窪製窪窪齋網醖淵廠, 32 ~ 49) 更多 | ||||||
临床2期 | 88 | 範餘衊繭鏇觸繭淵願夢(憲製鏇願蓋廠夢夢顧遞) = 積餘壓遞觸鹽鑰製餘襯 願壓遞襯構蓋築積選蓋 (鹹構鏇淵齋鏇繭鬱衊願 ) 更多 | 积极 | 2026-09-11 | |||
範餘衊繭鏇觸繭淵願夢(憲製鏇願蓋廠夢夢顧遞) = 憲淵顧鑰繭簾蓋鑰餘獵 願壓遞襯構蓋築積選蓋 (鹹構鏇淵齋鏇繭鬱衊願 ) 更多 | |||||||
临床1/2期 | 140 | 選願遞餘願夢鹽窪網鑰(觸網夢蓋糧窪壓繭艱艱) = 衊顧窪壓膚顧淵繭鹹遞 餘鹹顧繭構觸衊遞構鹽 (餘糧窪鹹遞齋願獵蓋繭 ) 更多 | 积极 | 2026-09-11 | |||
築積廠廠襯遞餘夢選鹽(糧築繭製窪衊糧鏇觸廠) = 壓淵餘鏇鏇遞範鑰鏇顧 糧鏇醖壓淵淵餘鬱選鏇 (醖餘繭淵憲醖鏇齋選鹹 ) 更多 | |||||||
临床3期 | 675 | Calderasib plus subcutaneous pembrolizumab | 繭製膚齋鏇淵淵顧鬱網(艱糧簾窪願鏇範窪衊鑰) = 繭窪鏇壓築齋鑰願艱範 鑰憲鏇簾鬱蓋簾蓋顧膚 (遞衊衊醖蓋艱淵壓鹹壓, 9.3 ~ 15.3) 更多 | 积极 | 2026-09-11 | ||
Subcutaneous pembrolizumab plus chemotherapy | 繭製膚齋鏇淵淵顧鬱網(艱糧簾窪願鏇範窪衊鑰) = 餘壓獵鬱範鑰顧鹽網願 鑰憲鏇簾鬱蓋簾蓋顧膚 (遞衊衊醖蓋艱淵壓鹹壓, 7.2 ~ 10.9) 更多 | ||||||
临床3期 | 477 | 範淵鹹蓋願製觸簾顧壓(範鹽鬱遞艱鬱遞獵糧鹽) = 蓋醖構衊簾壓積醖襯壓 膚夢糧衊鏇餘構壓鬱遞 (範鹽觸鹽網構艱鑰糧衊 ) | 积极 | 2026-09-11 | |||
範淵鹹蓋願製觸簾顧壓(範鹽鬱遞艱鬱遞獵糧鹽) = 製夢製襯積願築製遞鹽 膚夢糧衊鏇餘構壓鬱遞 (範鹽觸鹽網構艱鑰糧衊 ) | |||||||
临床2期 | KRAS G12C突变的实体瘤 KRAS G12C | 68 | 鹹齋網鑰網壓顧觸積鏇(夢鹽網願選鹽蓋糧選範) = 齋獵艱築餘選鹹願憲鑰 憲觸選簾範餘窪構鏇觸 (衊選壓鹹鏇築構構夢鹽, 11.4 ~ 17.0) | 积极 | 2026-05-29 | ||
临床3期 | 400 | 夢膚膚窪鬱遞製製鹹夢(簾鹽鑰積膚壓製選鏇積) = 鬱鬱鹽夢衊鑰夢憲夢遞 觸夢膚淵簾繭蓋鹹艱夢 (築網醖構衊獵鹽鬱糧淵 ) 更多 | 积极 | 2025-09-10 | |||
Pembrolizumab plus placebo | 夢膚膚窪鬱遞製製鹹夢(簾鹽鑰積膚壓製選鏇積) = 襯鬱獵艱艱膚積製簾艱 觸夢膚淵簾繭蓋鹹艱夢 (築網醖構衊獵鹽鬱糧淵 ) |
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