Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04353375
Status:
RECRUITING
Last Update Posted:
2023-07-06
First Post:
2020-04-16
Brief Title:
Phase 2 Study of HMPL-453 Tartrate in Advanced Intrahepatic Cholangiocarcinoma
Sponsor:
Hutchmed
Organization:
Hutchmed
Study Overview
Official Title:
An Open-Label Single-Arm Multicenter Phase 2 Clinical Study to Evaluate the Efficacy Safety and Pharmacokinetics of HMPL-453 Tartrate in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 FusionRearrangement
Status:
RECRUITING
Status Verified Date:
2023-07
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:
The goal of this clinical trial is to evaluate in patients with advanced intrahepatic cholangiocarcinoma harboring FGFR2 fusionrearrangement The main questions it aims to answer are
To evaluate the objective response rate ORR of HMPL-453 tartrate in the treatment of patients with advanced intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor FGFR 2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance Participants will receive HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Days 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle
To evaluate the objective response rate ORR of HMPL-453 tartrate in the treatment of patients with advanced intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor FGFR 2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance Participants will receive HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Days 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle
Detailed Description:
This is an open-label single-arm multicenter phase 2 clinical study to evaluate the efficacy and safety of HMPL-453 tartrate in the treatment of patients with advanced ICC harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance The study consists of cohort 1 and cohort 2
Cohort 1 Approximately 12 patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance are planned to be enrolled in this cohort to receive HMPL-453 tartrate 150 mg administered orally once daily QD continuously in 21-day cycles
Cohort 2 A total of approximately 113-116 patients are planned to be enrolled in this cohort divided into safety run-in and extension phases Approximately 6 to 9 patients with solid tumors who failed standard treatment or had intolerable toxicity will be enrolled into the first phase safety run-in phase to receive HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Day 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle Dose limiting toxicities DLT observation period consists of 28 days in which a cycle of treatment will be received Patients will enter second stage of cohort 2 extension phase after completion of safety run-in assessments Approximately 20 patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance will receive HMPL-453 tartrate 300 mg QD orally administered for 14 consecutive days Day 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle Based on the efficacy and safety data of the already enrolled patients and after reaching an agreement with China Center for Drug Evaluation approximately 90 additional patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance are being enrolled to support registration submission as the registration study stage of this study receiving HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Days 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle
Cohort 1 Approximately 12 patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance are planned to be enrolled in this cohort to receive HMPL-453 tartrate 150 mg administered orally once daily QD continuously in 21-day cycles
Cohort 2 A total of approximately 113-116 patients are planned to be enrolled in this cohort divided into safety run-in and extension phases Approximately 6 to 9 patients with solid tumors who failed standard treatment or had intolerable toxicity will be enrolled into the first phase safety run-in phase to receive HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Day 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle Dose limiting toxicities DLT observation period consists of 28 days in which a cycle of treatment will be received Patients will enter second stage of cohort 2 extension phase after completion of safety run-in assessments Approximately 20 patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance will receive HMPL-453 tartrate 300 mg QD orally administered for 14 consecutive days Day 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle Based on the efficacy and safety data of the already enrolled patients and after reaching an agreement with China Center for Drug Evaluation approximately 90 additional patients with locally advanced unresectable or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 fusionsrearrangements after at least one line of systemic treatment failure or intolerance are being enrolled to support registration submission as the registration study stage of this study receiving HMPL-453 tartrate 300 mg QD orally for 14 consecutive days Days 1 to 14 followed by 7 days off Day 15 to 21 21 days as a treatment cycle
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