A Phase Ib/II Study of BY101298 , an Oral DNA-PK Inhibitor, Combined With Radiotherapy in Patients With Malignant Solid Tumors
NCT Number: NCT06524804
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Solid Tumor, Adult
Interventions: DRUG: BY101298 Capsules|RADIATION: palliative radiotherapy|DRUG: BY101298 Capsules|RADIATION: curative radiotherapy
Sponsor: Chengdu Baiyu Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-05-15
Completion Date: 2026-06-30
Locations: Cancer Hospital Affiliated to Shandong First Medical University / Shandong Cancer Research Institute / Shandong Cancer Hospital, Jinan, Shandong, 250117, China

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.

Primary Outcome Measures: To evaluate the safety and tolerability of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., Grade and frequency of adverse events and serious adverse events, through study completion (an average of 1.5 years)|To assess the maximum tolerated dose (MTD), Incidence of Dose limiting Toxicities (DLTs), through study completion (an average of 1.5 years)|To determine the recommended phase II dose of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., the recommended phase II dose（RP2D）, through study completion (an average of 1.5 years)
Secondary Outcome Measures: To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., AUC, through study completion (an average of 1.5 years)|To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., Cmax, through study completion (an average of 1.5 years)|To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., Cmax,ss, through study completion (an average of 1.5 years)|To evaluate the pharmacokinetic (PK) characteristics of BY101298 combined with radiotherapy in patients with advanced malignant solid tumors., Cmin,ss, through study completion (an average of 1.5 years)|To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors., ORR, through study completion (an average of 1.5 years)|To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors., DCR, through study completion (an average of 1.5 years)|To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors., DOR, through study completion (an average of 1.5 years)|To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors., PFS, through study completion (an average of 1.5 years)|To evaluate the preliminary efficacy of BY101298 combined with radiotherapy in patients advanced malignant solid tumors., OS, through study completion (an average of 1.5 years)