A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity

Summary

This study aims to investigate the safety and efficacy of the IL-22BP/LNP compound in patients with refractory malignant solid tumors, such as advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma, who have failed second-line treatment, have advanced recurrence or metastatic malignant solid tumors.

Timeline

Start

2025-01-20

Primary completion

2026-02-20

Completion

2026-02-20

Publications

• Background Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
• Background Gersten O, Barbieri M. Evaluation of the Cancer Transition Theory in the US, Select European Nations, and Japan by Investigating Mortality of Infectious- and Noninfectious-Related Cancers, 1950-2018. JAMA Netw Open. 2021 Apr 1;4(4):e215322. doi: 10.1001/jamanetworkopen.2021.5322.
• Background Ibarra AMC, Cecatto RB, Motta LJ, Dos Santos Franco AL, de Fatima Teixeira da Silva D, Nunes FD, Hamblin MR, Rodrigues MFSD. Photodynamic therapy for squamous cell carcinoma of the head and neck: narrative review focusing on photosensitizers. Lasers Med Sci. 2022 Apr;37(3):1441-1470. doi: 10.1007/s10103-021-03462-3. Epub 2021 Dec 2.
• Background Sayed N, Allawadhi P, Khurana A, Singh V, Navik U, Pasumarthi SK, Khurana I, Banothu AK, Weiskirchen R, Bharani KK. Gene therapy: Comprehensive overview and therapeutic applications. Life Sci. 2022 Apr 1;294:120375. doi: 10.1016/j.lfs.2022.120375. Epub 2022 Feb 3.
• Background Arjmand B, Larijani B, Sheikh Hosseini M, Payab M, Gilany K, Goodarzi P, Parhizkar Roudsari P, Amanollahi Baharvand M, Hoseini Mohammadi NS. The Horizon of Gene Therapy in Modern Medicine: Advances and Challenges. Adv Exp Med Biol. 2020;1247:33-64. doi: 10.1007/5584_2019_463.
• Background Markota A, Endres S, Kobold S. Targeting interleukin-22 for cancer therapy. Hum Vaccin Immunother. 2018;14(8):2012-2015. doi: 10.1080/21645515.2018.1461300. Epub 2018 May 17.
• Background Kempski J, Giannou AD, Riecken K, Zhao L, Steglich B, Lucke J, Garcia-Perez L, Karstens KF, Wostemeier A, Nawrocki M, Pelczar P, Witkowski M, Nilsson S, Konczalla L, Shiri AM, Kempska J, Wahib R, Brockmann L, Huber P, Gnirck AC, Turner JE, Zazara DE, Arck PC, Stein A, Simon R, Daubmann A, Meiners J, Perez D, Strowig T, Koni P, Kruglov AA, Sauter G, Izbicki JR, Guse AH, Rosch T, Lohse AW, Flavell RA, Gagliani N, Huber S. IL22BP Mediates the Antitumor Effects of Lymphotoxin Against Colorectal Tumors in Mice and Humans. Gastroenterology. 2020 Oct;159(4):1417-1430.e3. doi: 10.1053/j.gastro.2020.06.033. Epub 2020 Jun 22.
• Background Hou X, Zaks T, Langer R, Dong Y. Lipid nanoparticles for mRNA delivery. Nat Rev Mater. 2021;6(12):1078-1094. doi: 10.1038/s41578-021-00358-0. Epub 2021 Aug 10.
• Background Kiaie SH, Majidi Zolbanin N, Ahmadi A, Bagherifar R, Valizadeh H, Kashanchi F, Jafari R. Recent advances in mRNA-LNP therapeutics: immunological and pharmacological aspects. J Nanobiotechnology. 2022 Jun 14;20(1):276. doi: 10.1186/s12951-022-01478-7.

Drugs

Indications