Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06524804
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
A Phase IbII Study of BY101298 an Oral DNA-PK Inhibitor Combined With Radiotherapy in Patients With Malignant Solid Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IbII Clinical Study Evaluating the Safety Tolerability Efficacy and Pharmacokinetic Characteristics of BY101298 Combined With Radiotherapy in Patients With Malignant Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 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 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None