A phase 1 open-label trial evaluating lartesertib in patients with advanced solid tumors (DDRiver™ Solid Tumors 410)1
SOLID TUMORS
Lartesertib is an investigational orally administered ATP-competitive inhibitor of ataxia telangiectasia mutated (ATM) protein kinase, a key component of the DNA damage response (DDR) pathway. In preclinical studies, lartesertib demonstrated subnanomolar potency and selectivity for ATM1-3
Study design | North America
Lartesertib 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 lartesertib, and it includes information about how the safety and efficacy of lartesertib will be measured and evaluated. Therefore, it is important to understand that lartesertib 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 European Medicines Agency or the US Food and Drug Administration, and there is no guarantee that lartesertib will be approved in the sought-after indication by any health authority worldwide.
a For a list of all inclusion and exclusion criteria, please visit https://clinicaltrials.gov/ct2/show/NCT04882917.
b Participants will receive lartesertib at the dose and schedule determined as the RDE in part 1A.
c Assessed by investigator per RECIST version 1.1.
ATM, ataxia telangiectasia mutated; ATP, adenosine triphosphate; DDR, DNA damage response; DLT, dose-limiting toxicity; DNA, deoxyribonucleic acid; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; OR, objective response; PFS, progression-free survival; 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/NCT04882917; 2. Zimmermann A, et al. Mol Cancer Ther. 2022;21(6):859-870;
3. Blackford N, Jackson P. Mol Cell. 2017;6(6):801-817.
The mechanisms in the DDRiver™ clinical trials program are under clinical investigation and have not been proven to be safe and effective. There is no guarantee that any therapies in the clinical trials program will be approved in the sought-after indication by any health authority worldwide. Clinical trial information is available at www.clinicaltrials.gov.
This website is intended for healthcare professionals in the US and Canada. For patient information, click here: https://clinicaltrials.emdgroup.com/.
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US-MULO-00083 June 2024