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Tuvusertib is being investigated in this clinical trial and has not been shown to be safe or effective for any purpose or disease. This page describes one of the clinical trials for tuvusertib, and it includes information about how the safety and efficacy of tuvusertib will be measured and evaluated. Therefore, it is important to understand that tuvusertib is not a treatment or therapy for cancer or any other disease, its use has not been approved by any health authority, such as the US Food and Drug Administration, and there is no guarantee that tuvusertib will be approved in the sought-after indication by any health authority worldwide.
a For a list of all inclusion and exclusion criteria and primary and secondary endpoints, please visit https://clinicaltrials.gov/ct2/show/NCT05396833.
b Tuvusertib will be administered orally once daily over a defined period of time in parts A1, A1.1, A2, A3, A2/3, and part B1 until disease progression, death, discontinuation, or end of study.
c Lartesertib will be administered orally once daily over a defined period of time in parts A1, A1.1, A2, A3, and A2/3 until disease progression, death, discontinuation, or end of study.
d Assessed by investigator per RECIST version 1.1.
e Assessed per RECIST version 1.1
ADA, antidrug antibody; ATR, ataxia telangiectasia mutated and Rad3 related; DDR, DNA damage response; DLT, dose-limiting toxicity; DNA, deoxyribonucleic acid; ECG, electrocardiogram; ECOG PS, Eastern Cooperative Oncology Group performance status; ICI, immune checkpoint inhibitor; LOF, loss of function; OR, objective response; PD, pharmacodynamics; PK, pharmacokinetics; QD, once daily; RDE, recommended dose for expansion; RECIST, Response Evaluation Criteria in Solid Tumors.
References
1. ClinicalTrials.gov. Accessed March 29, 2024. https://clinicaltrials.gov/ct2/show/NCT05396833; 2. Roidos P, et al. Nat Commun. 2020;11(1):4077; 3.Siu L, et al. Cancer Res. 2024;84 (Supp 7): CT063.