Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632262
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
A Phase 2 Clinical Study of ABSK061 and ABSK043
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase 2 Multicenter Open-Label Clinical Study to Evaluate the Safety and Efficacy of ABSK061 and ABSK043 With or Without Chemotherapy in Patients With MetastaticUnresectable Solid Tumors With FGFR23 Alterations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to evaluate the anti-tumor activity of ABSK061 ABSK043 in terms of overall response rate ORR in in Patients with MetastaticUnresectable Solid Tumors with FGFR23 Alterations
Detailed Description:
ABSK061 is a selective and potent pan FGFR 23 inhibitor with demonstrated clinical activity in participants with a variety of FGFR inhibitors in a variety of solid tumors
ABSK043 is a small molecule PD-L1 inhibitor with good oral bioavailability high selectivity and high activity and is currently being developed for the treatment of multiple cancers and potential non-oncology indications
This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype The study consists of screening phase treatment phase and the post treatment follow-up phase from the end of treatment visit until the participant has died withdraws consent is lost to follow-up or the end of study whichever comes first End of study is considered of the last visit of the last patient in this trial or the procedures shown in the schedule or 12 months after the first dose of the last enrolled patient whichever occurs first
ABSK043 is a small molecule PD-L1 inhibitor with good oral bioavailability high selectivity and high activity and is currently being developed for the treatment of multiple cancers and potential non-oncology indications
This study targets the underlying altered biology of FGFR-driven tumors irrespective of solid tumor histology subtype The study consists of screening phase treatment phase and the post treatment follow-up phase from the end of treatment visit until the participant has died withdraws consent is lost to follow-up or the end of study whichever comes first End of study is considered of the last visit of the last patient in this trial or the procedures shown in the schedule or 12 months after the first dose of the last enrolled patient whichever occurs first
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