NCT06524804

A Phase Ib/II Study of BY101298 , an Oral DNA-PK Inhibitor, Combined with Radiotherapy in Patients with Malignant Solid Tumors

A Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetic Characteristics of BY101298 Combined with Radiotherapy in Patients with Malignant Solid Tumors

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 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). By inhibiting DNA-PK activity to inhibit DSBs repair, BY101298 may synergistically improve the killing effect on tumor cells, reduce the risk of local recurrence and metastasis, and improve the clinical benefit of cancer patients when combing with radiotherapy. Primary objective is to assess the safety and tolerability; RP2D. The secondary Objectives are to characterize the pharmacokinetic (PK) profile of BY101298 and to assess the preliminary efficacy.

Conditions

• Solid Tumor, Adult

Interventions

Type	Name	Description
DRUG	BY101298 Capsules	An oral DNA-PK Inhibitor
RADIATION	palliative radiotherapy	Undergo palliative radiotherapy
DRUG	BY101298 Capsules	An oral DNA-PK Inhibitor
RADIATION	curative radiotherapy	Undergo curative radiotherapy

Timeline

• Start date: 2024-05-15
• Primary completion: 2024-10-18
• Completion: 2024-10-18
• First posted: 2024-07-29
• Last updated: 2024-12-18

Locations

1 site across 1 country: China