Table of contents
- Clinical trials overview
- Recurrent astrocytoma study
- Advanced breast cancer study
- Epithelial ovarian cancer study
- What the trials measure
- Who the trials are for
Clinical trials overview
Three authorised interventional studies are investigating Tuvusertib in different cancers.[1][2][1] These trials are in Phase 1 or Phase 2, which means they are still testing safety, dose selection, and early signs of benefit.[1][2][1]
The studies include Tuvusertib used alone and Tuvusertib used with other cancer medicines.[1][2][1] Each trial is focused on a specific patient group and has different outcome measures.[1][2][1]
Recurrent astrocytoma study
One Phase 2 trial is studying Tuvusertib in people with first recurrence of IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma.[1] Astrocytoma is a brain tumor that starts in brain support cells, and “recurrent” means the cancer has come back after previous treatment.[1]
The main goal is to evaluate how well Tuvusertib works as a single treatment, using progression-free survival (the time before the tumor gets worse) measured by MRI and RANO 2.0 rules.[1] The primary endpoint is the 6-month progression-free survival rate, which means the share of patients alive and without cancer growth at 6 months after the first dose.[1]
This study plans to enroll 56 participants and is currently authorised.[1]
Advanced breast cancer study
Another trial is a Phase 1/II study in hormone receptor-positive, HER2-negative advanced breast cancer that has become resistant to CDK4/6 inhibitor plus aromatase inhibitor-based endocrine treatment.[2] Endocrine treatment means hormone-based treatment, and resistance means the cancer no longer responds well to it.[2]
This study tests Tuvusertib with fulvestrant in people whose tumors also show homologous recombination deficiency, oncogenic driver activation, or other molecular changes linked to replication stress.[2] Replication stress means the cancer cells may have trouble copying their DNA correctly.[2]
The Phase 1 part looks for the maximum tolerated dose and a recommended phase II dose, while the Phase 2 part looks at safety and early benefit using the clinical benefit rate.[2] The primary outcome is dose-limiting toxicity, and the study plans to enroll 57 participants.[2]
Epithelial ovarian cancer study
A third Phase 2 study is in people with epithelial ovarian cancer that progressed after prior PARP inhibitor therapy.[1] “Progressed” means the cancer grew or came back despite earlier treatment.[1]
This trial compares Tuvusertib combinations with other treatment approaches, including Tuvusertib with niraparib and Tuvusertib with lartesertib, and it also includes Tuvusertib monotherapy in later parts of the study.[1] The study is designed to help choose the best combination and the best dose for future testing.[1]
The main outcomes are confirmed objective response according to RECIST v1.1 and the number of participants with treatment-emergent adverse events, serious adverse events, and related adverse events.[1] The study plans to enroll 130 participants and is authorised.[1]
What the trials measure
The trials measure different endpoints depending on the cancer and study phase.[1][2][1] In the astrocytoma study, the key measure is 6-month progression-free survival.[1]
In the breast cancer study, the main focus is dose-limiting toxicity, which helps researchers understand whether the treatment dose can be given safely.[2] The study also looks for early signs of benefit through clinical benefit rate.[2]
In the ovarian cancer study, the main measure is confirmed objective response, which shows whether tumors shrink or improve on scans, along with safety outcomes such as treatment-emergent adverse events.[1]
Who the trials are for
These trials are not for all cancer patients; they are for specific groups with certain tumor types and treatment histories.[1][2][1] The astrocytoma study focuses on people with a first recurrence and specific gene changes.[1]
The breast cancer study focuses on people with hormone receptor-positive, HER2-negative advanced disease that has resisted earlier endocrine treatment and has features such as HRD or other molecular alterations.[2] The ovarian cancer study focuses on epithelial ovarian cancer after prior PARP inhibitor therapy.[1]
Because these are early and mid-stage trials, participation usually depends on meeting the study’s detailed eligibility rules and having the right cancer features for that trial.[1][2][1]
