Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04716634
Status:
COMPLETED
Last Update Posted:
2024-03-25
First Post:
2021-01-13
Brief Title:
Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected Solid Tumors
Sponsor:
BeiGene
Organization:
BeiGene
Study Overview
Official Title:
A Multicenter Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-10
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:
This is an open label multicenter Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic unresectable gastric cancer GC or colorectal cancer CRC or Non-small Cell Lung Cancer NSCLC The study will be conducted in 2 parts Part 1 will be the safety run-in stage to determine dose-limiting toxicity DLT and recommended Phase 2 dose RP2D Part 2 will assess the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate ORR and other efficacy and safety profiles
Detailed Description:
This is an open label multicenter Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic unresectable GC and CRC or NSCLC The study will be conducted in 2 parts
Part 1 of the study will be the safety run-in stage which assesses dose-limiting toxicities DLTs and RP2D Part 2 will begin at RP2D Patients enrolled in Part 1 at RP2D will be counted towards Part 2 up to approximately 30 patients per cohort will be enrolled at RP2D
The primary outcome measure of the study is ORR as assessed by the investigator per RECIST v11 Tislelizumab and fruquintinib will be administered until disease progression intolerable toxicity death withdrawal of consent or until the study terminates
Part 1 of the study will be the safety run-in stage which assesses dose-limiting toxicities DLTs and RP2D Part 2 will begin at RP2D Patients enrolled in Part 1 at RP2D will be counted towards Part 2 up to approximately 30 patients per cohort will be enrolled at RP2D
The primary outcome measure of the study is ORR as assessed by the investigator per RECIST v11 Tislelizumab and fruquintinib will be administered until disease progression intolerable toxicity death withdrawal of consent or until the study terminates
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTR20211070 | OTHER | ChinaDrugTrials | None |