Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433726
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-13
Brief Title:
A Phase l Study of By101921 an Oral PARP7 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 Multi-center Open-label Dose-escalation Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics PK and Anti-tumor Activity of BY101921 Monotherapy in Patients With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-05
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:
BY101921 is a novel small molecule being developed as a PARP7 inhibitor which acts on the PARP7 catalytic subunit for the treatment of solid tumors PARP7 is a member of the monoPARP family and involved in various biological processes such as gene expression protein degradation and cellular stress response The results of non-clinical studies showed BY101921 was a potent inhibitor of PARP7 and had good selectivity
The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors This study will also evaluate pharmacokinetic PK profile preliminary anti-tumor activity major metabolites and biomarkers in patients with refractory or metastatic solid tumors
The primary objective is to assess the safety and tolerability and MTD of BY101921 in patients with refractory or metastatic solid tumors This study will also evaluate pharmacokinetic PK profile preliminary anti-tumor activity major metabolites and biomarkers in patients with refractory or metastatic solid tumors
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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