1. First-in-human phase 1 study of KHK2455 monotherapy and in combination with mogamulizumab in patients with advanced solid tumors.
作者: Timothy A Yap.;Olivier Rixe.;Capucine Baldini.;Ursa Brown-Glaberman.;Sergey Efuni.;David S Hong.;Christophe Massard.;Jameel Muzaffar.;Andreea Varga.;Emrullah Yilmaz.;Yuta Ikawa.;Lisa H Shiue.;Yi Liu.;Matthew W Hruska.;Henry Zhao.;Akihiro Tokunaga.;Solmaz Sahebjam.
来源: Cancer. 2025年131卷13期e35939页
Indoleamine 2,3-dioxygenase 1 (IDO1) is a heme-containing enzyme that degrades tryptophan (Trp) to kynurenine (Kyn), which suppresses effector T cells and reduces antitumor activity. KHK2455 is a long-acting selective IDO1 inhibitor that blocks the heme component of the IDO holoenzyme. Mogamulizumab is a humanized immunoglobulin G1 monoclonal antibody targeting CCR4. KHK2455 + mogamulizumab demonstrated enhanced antitumor activity in preclinical studies, which led to a first-in-human, two-part, multicenter, open-label, phase 1, dose-escalation, cohort-expansion trial (ClinicalTrials.gov identifier NCT02867007) evaluating the safety/tolerability, pharmacokinetics, and IDO1 activity of KHK2455 alone and in combination with mogamulizumab in patients with treatment-refractory advanced solid tumors.
2. Phase 1 first-in-human dose-escalation study of IMSA101, a novel cyclic di-nucleotide STING agonist, for patients with advanced solid tumor malignancies.
作者: Jay Jacoby.;Deva Mahalingam.;Angela Alistar.;Edward Garmey.;Syed Kazmi.;Teresa Mooneyham.;Lijun Sun.;Timothy A Yap.;Peter Vu.;Justin Moser.
来源: J Immunother Cancer. 2025年13卷6期
Despite progress in cancer therapeutics, there remains an unmet need for treatment of advanced solid tumors. The cGAS-cGAMP-STING pathway plays a pivotal role in innate antitumor immunity processes. IMSA101 is a small molecule analog of cGAMP and a potent STING agonist. Preclinical studies demonstrate antitumor activity of IMSA101 alone and in combination with immune-checkpoint inhibitors (ICIs).
3. Efficacy and safety of regorafenib plus biweekly trifluridine/tipiracil for refractory metastatic colorectal cancer: a multicenter single-arm phase II trial.
作者: Xiangling Wang.;Zhen Li.;Dan Sha.;Haipeng Ren.;Cuihua Yi.;Shuguang Li.;Peng Wang.;Yunxia Chu.;Changlun Li.;Guanglian Shan.;Jian Wang.;Xiaorong Yang.;Jing Hao.
来源: Oncologist. 2025年30卷6期
Both regorafenib and trifluridine/tipiracil (TAS-102) monotherapies have shown significant but limited survival benefits in metastatic colorectal cancer (mCRC) cases who progress after standard treatments. This study aimed to evaluate the efficacy and safety of regorafenib plus biweekly TAS-102 in refractory mCRC.
4. Garsorasib, a KRAS G12C inhibitor, with or without cetuximab, an EGFR antibody, in colorectal cancer cohorts of a phase II trial in advanced solid tumors with KRAS G12C mutation.
作者: Dan-Yun Ruan.;Hao-Xiang Wu.;Ye Xu.;Pamela N Munster.;Yanhong Deng.;Gary Richardson.;Dong Yan.;Myung-Ah Lee.;Keun-Wook Lee.;Hongming Pan.;Steven Hager.;Xingya Li.;Shaozhong Wei.;Xinfang Hou.;Craig Underhill.;Michael Millward.;Ina Nordman.;Jingdong Zhang.;Jianzhen Shan.;Guohong Han.;Jaspreet Grewal.;Shirish M Gadgeel.;Rachel E Sanborn.;Seok Jae Huh.;Xiaohua Hu.;Yihong Zhang.;Ziyong Xiang.;Laisheng Luo.;Xiaoxi Xie.;Zhe Shi.;Yaolin Wang.;Ling Zhang.;Feng Wang.;Rui-Hua Xu.
来源: Signal Transduct Target Ther. 2025年10卷1期189页
Mutations in the KRAS gene have long been implicated in the pathogenesis of colorectal cancer (CRC). KRAS G12C inhibitors overcome the "undruggable" challenge, enabling precision therapy. Garsorasib (D-1553), a highly potent and selective KRAS G12C inhibitor, has demonstrated promising anti-tumor activity and favorable safety profile in early clinical trials. We conducted an open-label, nonrandomized phase II trial (ClinicalTrials.gov, NCT04585035) to assess the safety and efficacy of garsorasib with or without cetuximab in KRAS G12C-mutated CRC. In the monotherapy cohort (n = 26), objective response rate (ORR) was 19.2% (95% CI, 6.6-39.4), disease control rate (DCR) was 92.3% (95% CI, 74.9-99.1), median progression-free survival (PFS) was 5.5 months (95% CI, 2.9-11.6) and median overall survival (OS) was 13.1 months (95% CI, 9.5-NE). In the combination cohort (n = 42), ORR was 45.2% (95% CI, 29.8-61.3), DCR was 92.9% (95% CI, 80.5-98.5), median PFS was 7.5 months (95% CI, 5.5-8.1), and median OS was not reached. Grade ≥3 treatment-related adverse events occurred in 5 (19.2%) and 6 (14.3%) patients in monotherapy and combination cohort, respectively. Garsorasib with or without cetuximab showed a promising efficacy and manageable safety profiles in heavily pretreated patients with KRAS G12C-mutated CRC, providing a potential new treatment approach for such population.
5. The value of nanocarbon contrast methylene blue based on dye-based tracer technology in sentinel lymph node biopsy for breast cancer: a systematic review and meta-analysis.
作者: Luhua Xia.;Zuowei Zou.;Le Chong.;Xinhua Wang.;Zhanfei Dong.;Yanping Zhao.
来源: PeerJ. 2025年13卷e19546页
The purpose of this study was to compare the diagnostic value of nanocarbon suspensions and methylene blue injections in sentinel lymph node biopsies of patients with breast cancer based on the dye method.
6. First-in-human phase I/II, open-label study of mRNA-2416 alone or combined with durvalumab in patients with advanced solid tumors and ovarian cancer.
作者: Ryan J Sullivan.;Oladapo O Yeku.;Deanna Teoh.;Shilpa Gupta.;Daniela Matei.;Andressa S Laino.;Jing Sun.;Lili Zhu.;Linh Van.;Stephanie Pascarella.;Sima J Zacharek.;Khanh T Do.;Antonio Jimeno.
来源: Oncologist. 2025年30卷6期
mRNA-2416 is a novel lipid nanoparticle-encapsulated messenger RNA (mRNA) encoding human OX40 ligand (OX40L) for intratumoral (Itu) injection. OX40L plus immune checkpoint inhibitor (ICI) increased preclinical antitumor activity, thus mRNA-2416 plus ICI may potentiate antitumor activity.
7. A phase II, multicenter, single-arm study of pemigatinib in patients with metastatic or unresectable colorectal cancer harboring FGFR alterations.
作者: Margaret C Wheless.;Tyler J Zemla.;Joleen M Hubbard.;John H Strickler.;Olumide B Gbolahan.;Luke Wilson.;Blake Waechter.;Fang-Shu Ou.;Andrew B Nixon.;Tanios S Bekaii-Saab.;Kristen K Ciombor.
来源: Oncologist. 2025年30卷6期
FGFR alterations are known to be driver alterations in several tumor types. We aimed to assess the efficacy of pemigatinib, an oral FGFR1-3 inhibitor, in patients with metastatic or unresectable colorectal cancer whose tumors harbored FGF/FGFR alterations.
8. Phase II study of rucaparib and nivolumab in patients with leiomyosarcoma.
作者: Sujana Movva.;Kenneth Seier.;Martina Bradic.;Karmelina Charalambous.;Evan Rosenbaum.;Ciara M Kelly.;Seth M Cohen.;Martee L Hensley.;Viswatej Avutu.;Lauren B Banks.;Jason E Chan.;Ping Chi.;Sandra D'Angelo.;Mark A Dickson.;Mrinal M Gounder.;Mary L Keohan.;Robert G Maki.;Angela Green.;Vicky Makker.;Maria M Rubinstein.;Sara Saunds.;Jae-Mun Cho.;Robert A Lefkowitz.;Joseph Erinjeri.;Li-Xuan Qin.;Ronak Shah.;Phillip Wong.;William Tap.
来源: J Immunother Cancer. 2025年13卷6期
Objective responses to immune checkpoint inhibitors (ICI) in leiomyosarcoma (LMS) are rare. Response rates may be increased by combination with other drugs known to promote immune infiltration, such as poly(ADP-ribose) polymerase (PARP) inhibitors, which have led to benefit in BRCA-altered uterine LMS. We therefore evaluated the combination of a PARP inhibitor, rucaparib, and the anti-programmed death receptor-1 monoclonal antibody, nivolumab, in patients with advanced LMS and investigated its effects on the tumor immune microenvironment.
9. Pegylated liposomal doxorubicin + cyclophosphamide followed by taxane as adjuvant therapy for early-stage breast cancer: a randomized controlled trial.
作者: Lichen Tang.;Min He.;Cuizhi Geng.;Zhimin Fan.;Rui Ling.;Guangdong Qiao.;Li Cai.;Ting Luo.;Feng Jin.;Haibo Wang.;Anqin Zhang.;Hongwei Zhang.;Xiaohua Zeng.;Xiaojia Wang.;Ming Jiang.;Zhonghua Wang.;Zhimin Shao.
来源: Oncologist. 2025年30卷6期
Pegylated liposomal doxorubicin (PLD) was shown to have comparable efficacy to doxorubicin, with significantly reduced cardiotoxicity. This study evaluated the cardiotoxicity and efficacy of the PLD-based regimen compared with those of the doxorubicin-based regimen as adjuvant therapy for early-stage breast cancer (BC).
10. Anlotinib combined with benmelstobart as a chemo-free first-line treatment in advanced esophageal squamous cell carcinoma: an exploratory multicenter, single-arm phase II clinical trial.
作者: Xiangrui Meng.;Xiuli Yang.;Yonggui Hong.;Wenkang Wang.;Zhiye Zhang.;Jin Xia.;Yunfang Chen.;Yue Zhou.;Taiying Lu.;Min Song.;Zhengzheng Shan.;Tao Wu.;Weilong Wu.;Ling Shen.;Lulu Guan.;Mingying Ma.;Lisen Wang.;Xi Luo.;Dao Xin.;Yihui Ma.;Guozhong Jiang.;Yu Qi.;Binghua Jiang.;Daoyu Zhang.;Biao Hu.;Xiaoying Wu.;Zuofu Peng.;Feng Wang.
来源: Mol Cancer. 2025年24卷1期175页
No combined antiangiogenic and PD-1/PD-L1 blockade therapy has been investigated as a chemo-free first-line treatment for advanced esophageal squamous cell carcinoma (ESCC). This study evaluates the efficacy and safety of anlotinib combined with benmelstobart as a chemo-free treatment in previously untreated advanced ESCC, and identifies potential predictive biomarkers using next-generation sequencing (NGS).
11. Intradermal priming to intravesical Bacillus Calmette-Guérin in non-muscle invasive bladder cancer: A translational research and phase I clinical trial.
作者: Luciana Saboya.;Keini Buosi.;Tiago Silva.;Elaine Candido.;Josiane Morari.;Licio A Velloso.;Shahrokh F Shariat.;Marcus V Sadi.;Leonardo O Reis.
来源: Oncol Res. 2025年33卷6期1495-1503页
To determine the safety and the role of modulating cytokines and proteases in the immune response to intravesical Bacillus Calmette-Guérin (BCG) when primed with systemic intradermal BCG.
12. Preclinical and clinical evaluation of intratumoral injection of an IL-12 expressing SKV-012 oncolytic virus for advanced solid tumors.
作者: Zheng Jiang.;Nian Yang.;Jing Jin.;Zongliang Zhang.;Huaqing Lu.;Long Xu.;Yongdong Chen.;Liyuan Jin.;Liangxue Zhou.;Hui Yang.;Jun Liu.;Weiwei Zhang.;Aiping Tong.;Xingchen Peng.
来源: J Immunother Cancer. 2025年13卷6期
SKV-012 is a novel engineered oncolytic virus (containing the viral neurovirulence ICP34.5 gene transcribed by the Survivin promoter with an upstream genetic component of interleukin-12 (IL-12) driven by the cytomegalovirus promoter) that preferentially replicates in tumors and helps stimulate antitumor immune responses.
13. Is Exercise During Androgen Deprivation Therapy Effective and Safe? A Randomized Controlled Trial.
作者: Lauri Rantaniemi.;Ilkka Jussila.;Aino Siltari.;Juha P Ahtiainen.;Annastiina Hakulinen.;Eeva Harju.;Jorma Sormunen.;Tupu Nordström.;Teuvo L J Tammela.;Teemu J Murtola.
来源: Scand J Med Sci Sports. 2025年35卷6期e70084页
To explore the benefits and safety of supervised and unsupervised exercise among localized and metastatic prostate cancer patients (PCa) during long-term androgen deprivation therapy (ADT). A total of 44 PCa patients were enrolled in this randomized controlled trial (RCT). Participants were randomized in a 1:1 ratio into the supervised exercise sessions group or the unsupervised home-based exercise group for three months. The primary outcomes assessed included quality of life (QoL), body composition, and metabolic markers, which were measured at baseline, after 3 months, and at 6 months. Muscle strength was evaluated exclusively in the supervised exercise group. The main statistical models used were the Mann-Whitney U-test for between-group comparisons and the Wilcoxon rank-sum test for within-group changes. No adverse events were reported during the exercise period. There were no significant differences in QoL, body composition, or metabolic profiles between the intervention and control groups. The supervised exercise group demonstrated significant improvement in emotional functioning (Z = -2.102, p = 0.036) and all exercise performance metrics (p < 0.001), with the most pronounced gains observed in the leg press (Z = -4.17, p < 0.001). Furthermore, a significant association was identified between strength improvements and enhanced self-evaluated physical function (p < 0.001). Supervised exercise is safe for patients with localized and metastatic PCa undergoing ADT and leads to significant improvements in emotional well-being and muscle strength, which translate to better self-reported physical function. Findings underscore the need for RCTs with longer intervention and follow-up periods on supervised exercise, especially in metastatic PCa patients. Trial Registration: ClinicalTrials.gov identifier: #NCT04050397.
14. Results of a phase 1/2 study of sacituzumab tirumotecan in patients with unresectable locally advanced or metastatic solid tumors refractory to standard therapies.
作者: Quchang Ouyang.;Jordi Rodon.;Yan Liang.;Xinhong Wu.;Qun Li.;Lihua Song.;Min Yan.;Zhongsheng Tong.;YunPeng Liu.;Zev A Wainberg.;Ying Wang.;Cuizhi Geng.;Susanna V Ulahannan.;Guohua Yu.;Manish R Sharma.;Xiang Wang.;Judy S Wang.;Alexander Spira.;Weihong Zhao.;Rachel E Sanborn.;Ying Cheng.;Xian Wang.;Gesha Liu.;Yaling Li.;Junyou Ge.;Elliot Chartash.;Omobolaji O Akala.;Yongmei Yin.
来源: J Hematol Oncol. 2025年18卷1期61页
Sacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate composed of an anti-TROP2 monoclonal antibody coupled to a cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) via a novel linker. We report results from the phase 1 dose-escalation cohorts in advanced solid tumors and phase 2 expansion cohorts for metastatic triple-negative breast cancer (TNBC) from the first-in-human MK-2870-001 (KL264-01) study (NCT04152499).
15. Intraoperatively preventive intraperitoneal perfusion chemotherapy with lobaplatin in colorectal cancer: a prospective, randomised, controlled, multicentre study.
作者: Hao Su.;Rui Zhang.;Yunfeng Li.;Yanke Li.;Wei Pei.;Zhigang Jie.;Zhimin Liu.;Meijin Huang.;Jing Zhuang.;Qian Jiang.;Ming Xie.;Guiying Wang.;Wenbin Zhang.;Ming Liu.;Jiansi Chen.;Zejun Wang.;Kang Wang.;Xinghong Zhang.;Guoxin Li.;Xiangfu Zeng.;Xinxiang Li.;Xuejun Sun.;Ju Wang.;Dongzhu Zeng.;Changlong Zhuang.;Haitao Zhou.;Xishan Wang.
来源: BMC Med. 2025年23卷1期336页
Peritoneal metastasis (PM) after radical surgery is an important cause of treatment failure in colorectal cancer (CRC). Intraoperative intraperitoneal perfusion chemotherapy may be an effective method for preventing postoperative PM in patients with CRC. This study aimed to explore the safety and feasibility of intraoperatively preventive intraperitoneal perfusion chemotherapy using lobaplatin for CRC.
16. Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors.
作者: Yingqi Hua.;Chongren Wang.;Fan Li.;Yanjie Han.;Dongqing Zuo.;Yu Lv.;Mengxiong Sun.;Peng Yuan.;Ruirong Yuan.;Fan Zhang.;Liang Ma.;Yan Wang.;Hui Wu.;Guoqing Zhou.;Qiang Lin.;Shuhang Wang.;Ning Li.;Yinying Lu.; .
来源: J Immunother Cancer. 2025年13卷6期
OVV-01 is a genetically engineered vesicular stomatitis virus oncolytic virus designed to selectively amplify in tumor cells and express tumor-associated antigen NY-ESO-1. This study was designed to evaluate the safety, tolerability, and efficacy of OVV-01 in patients with advanced solid tumors.
17. The younger women's wellness after cancer program: results from feasibility testing in Aotearoa New Zealand (the 'Kōwhai study').
作者: Janine P Porter-Steele.;Katrina J Sharples.;Bobbi B Laing.;Sarah Benge.;Sarah M Balaam.;Natalie K Vear.;Michael P N Findlay.;Ian D Campbell.;Marion J J Kuper-Hommel.;Debra J Anderson.;David J Porter.;Alexandra L McCarthy.
来源: Support Care Cancer. 2025年33卷7期546页
This paper reports the feasibility testing of the Younger Women's Wellness after Cancer Program in Aotearoa New Zealand (the 'Kōwhai Study') by examining (a) intervention uptake, adherence, and sustainability over time and (b) the feasibility of the proposed trial methods.
18. Sacituzumab tirumotecan versus docetaxel for previously treated EGFR-mutated advanced non-small cell lung cancer: multicentre, open label, randomised controlled trial.
作者: Wenfeng Fang.;Xingya Li.;Qiming Wang.;Xiangjiao Meng.;Wei Zheng.;Longhua Sun.;Wenxiu Yao.;Wu Zhuang.;Yun Fan.;Minglei Zhuo.;Yongzhong Luo.;Zhiye Zhang.;Xia Song.;Runxiang Yang.;Jiacheng Yang.;Xiaoping Jin.;Yina Diao.;Junyou Ge.;Li Zhang.
来源: BMJ. 2025年389卷e085680页
To compare the efficacy and safety of sacituzumab tirumotecan (sac-TMT) with docetaxel in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) after previous treatment failure with EGFR-tyrosine kinase inhibitors and platinum based chemotherapy.
19. Phase II trial dedicated to non-selected, pretreated cutaneous angiosarcoma: Efficacy of nivolumab (AngioCheck Study).
作者: Yasuhiro Fujisawa.;Kenjiro Namikawa.;Shoichiro Ishitsuki.;Koji Yoshino.;Taiki Isei.;Hiroshi Kato.;Teruki Yanagi.;Yuki Yamamoto.;Hiroshi Uchi.;Masahito Yasuda.;Kazushi Maruo.;Eiji Sugihara.;Atsushi Otsuka.
来源: Eur J Cancer. 2025年224卷115537页
Angiosarcoma is a rare and aggressive malignancy with limited treatment options. This phase II, multicenter, open-label, single-arm study (AngioCheck) evaluated the efficacy and safety of nivolumab in patients with cutaneous angiosarcoma previously treated with taxane-based chemotherapy.
20. TCHL - a phase II neo-adjuvant study assessing TCH (docetaxel, carboplatin and trastuzumab) and TCHL (docetaxel, carboplatin, trastuzumab and lapatinib) in HER-2 positive breast cancer patients: a 5-year follow-up with serum biomarker analysis.
作者: John Crown.;Alex J Eustace.;Denis M Collins.;Maccon Keane.;Linda Coate.;John Kennedy.;Seamus O'Reilly.;Catherine Kelly.;Miriam O'Connor.;Michael Martin.;Conleth Murphy.;Karen Duffy.;Janice Walshe.;Giuseppe Gullo.;Thamir Mahgoub.;Alberto Alvarez-Iglesias.;Imelda Parker.;Vicky Donachie.;Ausra Teiserskiene.;Stephen F Madden.;Brian Moulton.;Norma O'Donovan.;Bryan T Hennessy.
来源: Acta Oncol. 2025年64卷751-760页
The docetaxel (T), carboplatin (C) and trastuzumab (H) regimen has been used in the (neo-) adjuvant treatment of HER2+ early stage breast cancer (ESBC). Lapatinib (L) a small molecule HER2 antagonist produces clinical responses following H failure.
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