drugset / Trial / NCT06736275
A Phase I Study on Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of SXRN Plasmid DNA Technique in Patients With Advanced Solid Tumors
Phase 0
Recruiting
28 enrolled
Jiangsu Nutai Biologics Co., Ltd
Chinese Academy of Medical Sciences · collabJiangsu GQ Pharma Co., Ltd. · collab
RandomizedSequentialTriple-blindTreatment
Summary
The purpose of this clinical trial is to evaluate the safety and tolerability of SXRN Plasmid DNA Technique in patients with advanced solid tumors.
Timeline
- Start
- 2024-09-02
- Primary completion
- 2027-10-06
- Completion
- 2027-12-09
Publications
- Background Garcia GE, Truong LD, Chen JF, Johnson RJ, Feng L. Adenosine A(2A) receptor activation prevents progressive kidney fibrosis in a model of immune-associated chronic inflammation. Kidney Int. 2011 Aug;80(4):378-88. doi: 10.1038/ki.2011.101. Epub 2011 Apr 20.
- Background Wang Q, Liu Y, Wu Y, Wen J, Man C. Immune function of miR-214 and its application prospects as molecular marker. PeerJ. 2021 Feb 16;9:e10924. doi: 10.7717/peerj.10924. eCollection 2021.
- Background Zhao L, Liu YW, Yang T, Gan L, Yang N, Dai SS, He F. The mutual regulation between miR-214 and A2AR signaling plays an important role in inflammatory response. Cell Signal. 2015 Oct;27(10):2026-34. doi: 10.1016/j.cellsig.2015.07.007. Epub 2015 Jul 11.
- Background Takayama K, Atagi S, Imamura F, Tanaka H, Minato K, Harada T, Katakami N, Yokoyama T, Yoshimori K, Takiguchi Y, Hataji O, Takeda Y, Aoe K, Kim YH, Yokota S, Tabeta H, Tomii K, Ohashi Y, Eguchi K, Watanabe K. Quality of life and survival survey of cancer cachexia in advanced non-small cell lung cancer patients-Japan nutrition and QOL survey in patients with advanced non-small cell lung cancer study. Support Care Cancer. 2016 Aug;24(8):3473-80. doi: 10.1007/s00520-016-3156-8. Epub 2016 Mar 22.
- Background Fearon KC, Voss AC, Hustead DS; Cancer Cachexia Study Group. Definition of cancer cachexia: effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr. 2006 Jun;83(6):1345-50. doi: 10.1093/ajcn/83.6.1345.
- Background Malik M, Michalak M, Radecka B, Gelej M, Jackowska A, Filipczyk-Cisarz E, Hetman K, Foszczynska-Kloda M, Kania-Zembaczynska B, Manka D, Orlikowska M, Rogowska-Dros H, Bodnar L. Prognostic Value of Sarcopenia in Metastatic Colorectal Cancer Patients Treated with Trifluridine/Tipiracil. J Clin Med. 2021 Oct 30;10(21):5107. doi: 10.3390/jcm10215107.
- Background Argiles JM, Busquets S, Stemmler B, Lopez-Soriano FJ. Cancer cachexia: understanding the molecular basis. Nat Rev Cancer. 2014 Nov;14(11):754-62. doi: 10.1038/nrc3829. Epub 2014 Oct 9.
- Background Loberg RD, Bradley DA, Tomlins SA, Chinnaiyan AM, Pienta KJ. The lethal phenotype of cancer: the molecular basis of death due to malignancy. CA Cancer J Clin. 2007 Jul-Aug;57(4):225-41. doi: 10.3322/canjclin.57.4.225.
- Background Scarpi E, Maltoni M, Miceli R, Mariani L, Caraceni A, Amadori D, Nanni O. Survival prediction for terminally ill cancer patients: revision of the palliative prognostic score with incorporation of delirium. Oncologist. 2011;16(12):1793-9. doi: 10.1634/theoncologist.2011-0130. Epub 2011 Oct 31.
- Background Mondello P, Mian M, Aloisi C, Fama F, Mondello S, Pitini V. Cancer cachexia syndrome: pathogenesis, diagnosis, and new therapeutic options. Nutr Cancer. 2015;67(1):12-26. doi: 10.1080/01635581.2015.976318. Epub 2014 Dec 16.