Ignite Creation Date:
2024-05-06 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04699643
Status:
UNKNOWN
Last Update Posted:
2021-01-07
First Post:
2020-12-29
Brief Title:
FGFR4 Inhibitor EVER4010001 in Combination With PD-1 Inhibitor Pembrolizumab in Patients With Advanced Solid Tumors
Sponsor:
EverNov Medicines Zhuhai Hengqin Co Ltd
Organization:
EverNov Medicines Zhuhai Hengqin Co Ltd
Study Overview
Official Title:
A Phase III Study of FGFR4 Inhibitor EVER4010001 in Combination With PD-1 Inhibitor Pembrolizumab in Patients With Advanced Solid Tumors With Dose Escalation and Expansion to Selected Indications
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
RECRUITING
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:
The purpose of this study is to determine the maximum tolerated dose MTD and recommended phase II dose RP2D of EVER4010001 in combination with Pembrolizumab in Patients with Advanced Solid Tumors And in phase II to assess the anti-tumor efficacy of EVER4010001 in combination with Pembrolizumab in treating selected indications using appropriate biomarkers
Detailed Description:
This is a phase III single arm multicenter study of EVER4010001 combination with Pembrolizumab in advanced solid tumor patients The primary endpoint of phase I will be Dose-limiting toxicities DLTs observed in combined administration of EVER4010001 and Pembrolizumab And the primary endpoint of phase II will be the ORR per RECIST v11 in all treated patients
Patients will be treated until progression requiring discontinuation of further treatment unacceptable toxicity study withdrawal or death whichever comes first Tumor response and progression will be assessed using RECIST v11 and assessment by investigator at the trail center will be sufficient for decisions on continuation of treatment All patients will visit the investigator at regular intervals for assessment of safety parameters and AEs
Patients will be treated until progression requiring discontinuation of further treatment unacceptable toxicity study withdrawal or death whichever comes first Tumor response and progression will be assessed using RECIST v11 and assessment by investigator at the trail center will be sufficient for decisions on continuation of treatment All patients will visit the investigator at regular intervals for assessment of safety parameters and AEs
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