In short
Clinical trials are studying Tuvusertib in several cancers, including recurrent astrocytoma, advanced breast cancer, and epithelial ovarian cancer. These studies are looking at safety, tolerability, and early signs of benefit in specific patient groups. They include Phase 1 and Phase 2 research.
Key points
- Clinical trials are studying Tuvusertib in three cancer settings: recurrent astrocytoma, advanced breast cancer, and epithelial ovarian cancer. The studies are authorised and include both Phase 1 and Phase 2 research. One trial looks at Tuvusertib alone in recurrent astrocytoma, while the others test it in combinations or compare combination treatment with monotherapy. The trial goals include safety, tolerability, dose finding, progression-free survival, objective response, and clinical benefit. Each study focuses on a specific patient group with defined tumor features or prior treatment history.
Clinical trials overview
Three authorised interventional studies are investigating Tuvusertib in different cancers. These trials are in Phase 1 or Phase 2, which means they are still testing safety, dose selection, and early signs of benefit.
The studies include Tuvusertib used alone and Tuvusertib used with other cancer medicines. Each trial is focused on a specific patient group and has different outcome measures.
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. Astrocytoma is a brain tumor that starts in brain support cells, and “recurrent” means the cancer has come back after previous treatment.
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. 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.
This study plans to enroll 56 participants and is currently authorised.
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. Endocrine treatment means hormone-based treatment, and resistance means the cancer no longer responds well to it.
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. Replication stress means the cancer cells may have trouble copying their DNA correctly.
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. The primary outcome is dose-limiting toxicity, and the study plans to enroll 57 participants.
Epithelial ovarian cancer study
A third Phase 2 study is in people with epithelial ovarian cancer that progressed after prior PARP inhibitor therapy. “Progressed” means the cancer grew or came back despite earlier treatment.
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. The study is designed to help choose the best combination and the best dose for future testing.
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. The study plans to enroll 130 participants and is authorised.
What the trials measure
The trials measure different endpoints depending on the cancer and study phase. In the astrocytoma study, the key measure is 6-month progression-free survival.
In the breast cancer study, the main focus is dose-limiting toxicity, which helps researchers understand whether the treatment dose can be given safely. The study also looks for early signs of benefit through clinical benefit rate.
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.
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. The astrocytoma study focuses on people with a first recurrence and specific gene changes.
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. The ovarian cancer study focuses on epithelial ovarian cancer after prior PARP inhibitor therapy.
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.