A phase 1 open-label trial evaluating tuvusertib in patients with metastatic or locally advanced unresectable solid tumors (DDRiver™ Solid Tumors 301)1
SOLID TUMORS
Tuvusertib is an investigational orally administered inhibitor of ataxia telangiectasia and Rad3-related (ATR) protein kinase, a key component of the DNA damage response (DDR) pathway. Based on preclinical studies, tuvusertib is a highly selective and potent inhibitor of ATR activity1-3
Study design | North America, Europe, and Asia
How do I enroll patients in DDRiver™ Solid Tumors 301?
Please contact us for more information on this trial, including how to enroll your patients
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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 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 tuvusertib 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/NCT04170153.
b Participants will receive tuvusertib at the dose and schedule determined as the RDE in part A1.
c Participants with a baseline body weight of <77 kg or a platelet count of <150,000 per mm3.
d Niraparib once daily will be combined with different doses of tuvusertib.
e Participants with a baseline body weight of ≥77 kg or a platelet count of ≥150,000 per mm3.
f Niraparib once daily will be combined with different doses of tuvusertib and schedule determined as RDE in subpart B1a.
g Assessed by investigator per RECIST version 1.1.
h Defined as an OR or stable disease for at least 6 months.
ATR, ataxia telangiectasia mutated and Rad3-related; CHK1, checkpoint kinase 1; DDR, DNA damage response; DLT, dose-limiting toxicity; DNA, deoxyribonucleic acid; DOR, duration of response; ECOG PS, Eastern Cooperative Oncology Group performance status; LOF, loss of function; OR, objective response; OS, overall survival; 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/NCT04170153; 2. Roidos P, et al. Nat Commun. 2020;11(1):4077; 3. Yap TA, et al. Clin Cancer Res. Published online February 26, 2024, doi:10.1158/1078-0432.CCR-23-2409.
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