A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of SXRN Injection in Patients With Cancer Cachexia

Summary

This is a clinical study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of SXRN Injection in cancer patients with anorexia-cachexia. Phase Ia employs a single-arm, open-label, dose-escalation design. Phase Ib, an extension of the study, utilizes a design of combination therapy with standard anti-tumor therapy for cancers including but not limited to pancreatic cancer, non-small cell lung cancer (NSCLC), and colon cancer.

Timeline

Start

2025-11-17

Primary completion

2026-11-09

Completion

2026-12-30

Publications

• Background Gagnon B, Murphy J, Simonyan D, Penafuerte CA, Sirois J, Chasen M, Tremblay ML. Cancer anorexia-cachexia syndrome is characterized by more than one inflammatory pathway. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1041-1053. doi: 10.1002/jcsm.13430. Epub 2024 Mar 13.
• Background Clamon G, Byrne MM, Talbert EE. Inflammation as a Therapeutic Target in Cancer Cachexia. Cancers (Basel). 2022 Oct 26;14(21):5262. doi: 10.3390/cancers14215262.
• 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 Day YJ, Marshall MA, Huang L, McDuffie MJ, Okusa MD, Linden J. Protection from ischemic liver injury by activation of A2A adenosine receptors during reperfusion: inhibition of chemokine induction. Am J Physiol Gastrointest Liver Physiol. 2004 Feb;286(2):G285-93. doi: 10.1152/ajpgi.00348.2003.
• Background Zhang H, Garcia JM. Anamorelin hydrochloride for the treatment of cancer-anorexia-cachexia in NSCLC. Expert Opin Pharmacother. 2015 Jun;16(8):1245-53. doi: 10.1517/14656566.2015.1041500. Epub 2015 May 6.
• Background Mochamat, Cuhls H, Marinova M, Kaasa S, Stieber C, Conrad R, Radbruch L, Mucke M. A systematic review on the role of vitamins, minerals, proteins, and other supplements for the treatment of cachexia in cancer: a European Palliative Care Research Centre cachexia project. J Cachexia Sarcopenia Muscle. 2017 Feb;8(1):25-39. doi: 10.1002/jcsm.12127. Epub 2016 Jul 20.
• Background Anderson LJ, Albrecht ED, Garcia JM. Erratum to: Update on Management of Cancer-Related Cachexia. Curr Oncol Rep. 2017 Mar;19(3):22. doi: 10.1007/s11912-017-0595-4. No abstract available.
• Background Dev R, Wong A, Hui D, Bruera E. The Evolving Approach to Management of Cancer Cachexia. Oncology (Williston Park). 2017 Jan 15;31(1):23-32.
• Background Kimura M, Naito T, Kenmotsu H, Taira T, Wakuda K, Oyakawa T, Hisamatsu Y, Tokito T, Imai H, Akamatsu H, Ono A, Kaira K, Murakami H, Endo M, Mori K, Takahashi T, Yamamoto N. Prognostic impact of cancer cachexia in patients with advanced non-small cell lung cancer. Support Care Cancer. 2015 Jun;23(6):1699-708. doi: 10.1007/s00520-014-2534-3. Epub 2014 Nov 29.
• 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 Jain R, Handorf E, Khare V, Blau M, Chertock Y, Hall MJ. Impact of Baseline Nutrition and Exercise Status on Toxicity and Outcomes in Phase I and II Oncology Clinical Trial Participants. Oncologist. 2020 Feb;25(2):161-169. doi: 10.1634/theoncologist.2019-0289. Epub 2019 Nov 20.
• Background Baracos VE, Martin L, Korc M, Guttridge DC, Fearon KCH. Cancer-associated cachexia. Nat Rev Dis Primers. 2018 Jan 18;4:17105. doi: 10.1038/nrdp.2017.105.
• Background Scherbakov N, Doehner W. Cachexia as a common characteristic in multiple chronic disease. J Cachexia Sarcopenia Muscle. 2018 Dec;9(7):1189-1191. doi: 10.1002/jcsm.12388. Epub 2019 Jan 13. No abstract available.
• Background Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.
• Background Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.

Drugs

Indications

No indication recorded.