Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462716
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-12
Brief Title:
A Phase l Study of By101298 an Oral DNA-PK Inhibitor in Patients With Advanced Solid Tumors
Sponsor:
Chengdu Baiyu Pharmaceutical Co Ltd
Organization:
Chengdu Baiyu Pharmaceutical Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety Tolerability and Pharmacokinetic Characteristics of BY101298 as Single-agent Therapyin Combination With Radiotherapy in Patients With Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None