drugset / Trial / NCT04976660
TT-4 As a Single Agent in Subjects with Advanced Selected Solid Tumors
NaSequentialOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.
Timeline
- Start
- 2022-12-15
- Primary completion
- 2023-06-01
- Completion
- 2023-09-30
Outcome
Outcome not reported
Stopped: “Tarus is conducting clinical development under a single IND, specifically IND for TT-10 (PORT-6). Tarus has withdrawn Study TT-4-101 under the TT-4 IND; however the TT-4 IND will remain active.”
Publications
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- Background Aherne CM, Kewley EM, Eltzschig HK. The resurgence of A2B adenosine receptor signaling. Biochim Biophys Acta. 2011 May;1808(5):1329-39. doi: 10.1016/j.bbamem.2010.05.016. Epub 2010 May 28.
- Background Allard B, Allard D, Buisseret L, Stagg J. The adenosine pathway in immuno-oncology. Nat Rev Clin Oncol. 2020 Oct;17(10):611-629. doi: 10.1038/s41571-020-0382-2. Epub 2020 Jun 8.
- Background Zhou Y, Chu X, Deng F, Tong L, Tong G, Yi Y, Liu J, Tang J, Tang Y, Xia Y, Dai Y. The adenosine A2b receptor promotes tumor progression of bladder urothelial carcinoma by enhancing MAPK signaling pathway. Oncotarget. 2017 Jul 25;8(30):48755-48768. doi: 10.18632/oncotarget.17835.
- Background Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.
- Background Horigome E, Fujieda M, Handa T, Katayama A, Ito M, Ichihara A, Tanaka D, Gombodorj N, Yoshiyama S, Yamane A, Yamada K, Horiguchi J, Shinozuka K, Oyama T, Nishiyama M, Rokudai S. Mutant TP53 modulates metastasis of triple negative breast cancer through adenosine A2b receptor signaling. Oncotarget. 2018 Oct 2;9(77):34554-34566. doi: 10.18632/oncotarget.26177. eCollection 2018 Oct 2.
- Background Vecchio EA, Tan CY, Gregory KJ, Christopoulos A, White PJ, May LT. Ligand-Independent Adenosine A2B Receptor Constitutive Activity as a Promoter of Prostate Cancer Cell Proliferation. J Pharmacol Exp Ther. 2016 Apr;357(1):36-44. doi: 10.1124/jpet.115.230003. Epub 2016 Jan 20.
- Background Lan J, Lu H, Samanta D, Salman S, Lu Y, Semenza GL. Hypoxia-inducible factor 1-dependent expression of adenosine receptor 2B promotes breast cancer stem cell enrichment. Proc Natl Acad Sci U S A. 2018 Oct 9;115(41):E9640-E9648. doi: 10.1073/pnas.1809695115. Epub 2018 Sep 21.
- Background Ma DF, Kondo T, Nakazawa T, Niu DF, Mochizuki K, Kawasaki T, Yamane T, Katoh R. Hypoxia-inducible adenosine A2B receptor modulates proliferation of colon carcinoma cells. Hum Pathol. 2010 Nov;41(11):1550-7. doi: 10.1016/j.humpath.2010.04.008.
- Background Ryzhov S, Novitskiy SV, Zaynagetdinov R, Goldstein AE, Carbone DP, Biaggioni I, Dikov MM, Feoktistov I. Host A(2B) adenosine receptors promote carcinoma growth. Neoplasia. 2008 Sep;10(9):987-95. doi: 10.1593/neo.08478.