Trials / Active Not Recruiting
Active Not RecruitingNCT06462716
A Phase l Study of By101298, an Oral DNA-PK Inhibitor, in Patients With Advanced Solid Tumors
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of BY101298 as Single-agent Therapy/in Combination With Radiotherapy in Patients With Malignant Solid Tumors
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Chengdu Baiyu Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BY101298 Capsules | An oral DNA-PK Inhibitor |
Timeline
- Start date
- 2023-04-25
- Primary completion
- 2024-12-31
- Completion
- 2025-06-30
- First posted
- 2024-06-17
- Last updated
- 2025-04-13
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06462716. Inclusion in this directory is not an endorsement.