drugset / Trial / NCT04851834
NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase 1/2, open-label, dose-exploration, combination/expansion study, which will start by evaluating the safety and tolerability of NTX-301, an oral DNMT1 inhibitor, as a monotherapy in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease. It will then explore the safety and tolerability of NTX-301 in combination with platinum-based therapy in patients with ovarian and bladder cancer. Optionally, the safety and tolerability of NTX-301 in combination with Temozolomide (TMZ) in patients with Isocitrate Dehydrogenase 1 (IDH1) mutated high-grade glioma will also be assessed.
Timeline
- Start
- 2021-08-25
- Primary completion
- 2022-11-08
- Completion
- 2022-11-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NTX-301 | Other / unclassified | — | Oral |
| Background | Carboplatin | Small molecule | — | — |
| Background | Cisplatin | Other / unclassified | — | — |
| Background | Temozolomide | Small molecule | — | Oral |