drugset / Trial / NCT05627960
First in Human Phase 1 Study of AG01 Anti-Progranulin/GP88 Antibody in Advanced Solid Tumor Malignancies
Phase 1
Recruiting
77 enrolled
A&G Pharmaceutical Inc.
University of Maryland Greenebaum Cancer Center · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This is a first in human phase 1 study of AG01 an anti-Progranulin/Glycoprotein88 (PGRN/GP88) antibody in patients with advanced solid tumors. AG01 is a recombinant monoclonal antibody expressed in a CHO production cell line. The antibody AG01 binds to human PGRN/GP88, expressed on cancer cells. This study will have a dose escalation portion (1A) to evaluate maximum tolerated dose (MTD) and/or maximum administered dose (MAD), the safety and tolerability of AG01treatment before the dose expansion portion (1B) of the study is initiated. The dose escalation portion of this study (1A) will also be used to determine the recommended phase 2 dose (RP2D) of AG01 antibody to be evaluated in the cohort expansion portion (1B).
Timeline
- Start
- 2022-02-14
- Primary completion
- 2026-06
- Completion
- 2026-11
Publications
- Background Serrero G. Potential of Theranostic Target Mining in the Development of Novel Diagnostic and Therapeutic Products in Oncology: Progranulin/GP88 as a Therapeutic and Diagnostic Target for Breast and Lung Cancers. Rinsho Byori. 2016 Nov;64(11):1296-1309.
- Background Tkaczuk KHR, Hawkins D, Yue B, Hicks D, Tait N, Serrero G. Association of Serum Progranulin Levels With Disease Progression, Therapy Response and Survival in Patients With Metastatic Breast Cancer. Clin Breast Cancer. 2020 Jun;20(3):220-227. doi: 10.1016/j.clbc.2019.11.010. Epub 2019 Dec 5.
- Background Koo DH, Do IG, Oh S, Lee YG, Kim K, Sohn JH, Park SK, Yang HJ, Jung YS, Park DI, Jeong KU, Kim HO, Kim H, Serrero G, Chun HK; KBSMC Colorectal Cancer Team. Prognostic Value of Progranulin in Patients with Colorectal Cancer Treated with Curative Resection. Pathol Oncol Res. 2020 Jan;26(1):397-404. doi: 10.1007/s12253-018-0520-7. Epub 2018 Oct 30.
- Background Greither T, Steiner T, Bache M, Serrero G, Otto S, Taubert H, Eckert AW, Kappler M. GP88/PGRN Serum Levels Are Associated with Prognosis for Oral Squamous Cell Carcinoma Patients. Biology (Basel). 2021 May 4;10(5):400. doi: 10.3390/biology10050400.
- Background Guha R, Yue B, Dong J, Banerjee A, Serrero G. Anti-progranulin/GP88 antibody AG01 inhibits triple negative breast cancer cell proliferation and migration. Breast Cancer Res Treat. 2021 Apr;186(3):637-653. doi: 10.1007/s10549-021-06120-y. Epub 2021 Feb 22.
- Background Serrero G, Hawkins DM, Bejarano PA, Ioffe O, Tkaczuk KR, Elliott RE, Head JF, Phillips J, Godwin AK, Weaver J, Hicks D, Yue B. Determination of GP88 (progranulin) expression in breast tumor biopsies improves the risk predictive value of the Nottingham Prognostic Index. Diagn Pathol. 2016 Aug 8;11(1):71. doi: 10.1186/s13000-016-0520-4.
- Background Edelman MJ, Feliciano J, Yue B, Bejarano P, Ioffe O, Reisman D, Hawkins D, Gai Q, Hicks D, Serrero G. GP88 (progranulin): a novel tissue and circulating biomarker for non-small cell lung carcinoma. Hum Pathol. 2014 Sep;45(9):1893-9. doi: 10.1016/j.humpath.2014.05.011. Epub 2014 Jun 5.
- Background Serrero G, Hawkins DM, Yue B, Ioffe O, Bejarano P, Phillips JT, Head JF, Elliott RL, Tkaczuk KR, Godwin AK, Weaver J, Kim WE. Progranulin (GP88) tumor tissue expression is associated with increased risk of recurrence in breast cancer patients diagnosed with estrogen receptor positive invasive ductal carcinoma. Breast Cancer Res. 2012 Feb 8;14(1):R26. doi: 10.1186/bcr3111.
- Background Arechavaleta-Velasco F, Perez-Juarez CE, Gerton GL, Diaz-Cueto L. Progranulin and its biological effects in cancer. Med Oncol. 2017 Nov 7;34(12):194. doi: 10.1007/s12032-017-1054-7.
- Background Abrhale T, Brodie A, Sabnis G, Macedo L, Tian C, Yue B, Serrero G. GP88 (PC-Cell Derived Growth Factor, progranulin) stimulates proliferation and confers letrozole resistance to aromatase overexpressing breast cancer cells. BMC Cancer. 2011 Jun 9;11:231. doi: 10.1186/1471-2407-11-231.
- Background Wong NC, Cheung PF, Yip CW, Chan KF, Ng IO, Fan ST, Cheung ST. Antibody against granulin-epithelin precursor sensitizes hepatocellular carcinoma to chemotherapeutic agents. Mol Cancer Ther. 2014 Dec;13(12):3001-12. doi: 10.1158/1535-7163.MCT-14-0012. Epub 2014 Sep 24.