drugset / Trial / NCT06462716
A Phase l Study of By101298, an Oral DNA-PK Inhibitor, in Patients With Advanced Solid Tumors
NaSingle-groupOpen-labelTreatment
Summary
BY101298 is an innovative DNA-dependent protein kinases (DNA-PK) highly selective small molecule inhibitor. DNA-dependent protein kinases (DNA-PK plays a key role in the NHEJ repair pathway to repair DNA double-strand breaks (DSBs). Primary objective is to assess the safety and tolerability of BY101298 in patients with advanced malignant solid tumors. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 in patients with advanced malignant solid tumors and to assess the preliminary efficacy of BY101298 in patients with advanced malignant solid tumors.
Timeline
- Start
- 2023-04-25
- Primary completion
- 2024-12-31
- Completion
- 2025-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BY101298 | Small molecule | 50 mg | Oral |
| Subject | BY101298 | Small molecule | 100 mg | Oral |
| Subject | BY101298 | Small molecule | 200 mg | Oral |
| Subject | BY101298 | Small molecule | 300 mg | Oral |
| Subject | BY101298 | Small molecule | 400 mg | Oral |