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A phase 1B open-label trial evaluating tuvusertib in combination with DNA damage response inhibitors or immune checkpoint inhibitors in patients with metastatic or locally advanced unresectable solid tumors (DDRiver™ Solid Tumors 320)1
 

ClinicalTrials.govNCT05396833

Location: North America and Europe

Status:NOW ENROLLING

GROUP 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

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Key inclusion criteriaa

  • Metastatic or locally advanced unresectable solid tumors refractory to standard therapy, or patients with no tolerance to standard of care

  • ECOG PS of ≤1

  • Adequate hematologic, hepatic, and renal function

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Key exclusion criteriaa

  • Any other clinical condition, including any uncontrolled disease state, that the investigator believes constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study

  • Any additional malignancy that is progressing and/or requires active treatment

  • Any chronic gastrointestinal disease that may preclude adequate absorption of oral medications

  • Previous organ transplant

Study design | North America and Europe

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How do I enroll patients in DDRiver™ Solid Tumors 320?

 

Please contact us for more information on this trial, including how to enroll your patients

LOCATION CITY Location POSTAL CODE COUNTRY STATUS

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.