Ignite Creation Date:
2024-05-06 @ 4:23 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04965753
Status:
TERMINATED
Last Update Posted:
2024-04-25
First Post:
2021-06-26
Brief Title:
FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors
Sponsor:
Foghorn Therapeutics Inc
Organization:
Foghorn Therapeutics Inc
Study Overview
Official Title:
A Phase 1 Multicenter Open-Label Dose Escalation and Expansion Study to Assess the Safety Tolerability Pharmacokinetics Pharmacodynamics and Clinical Activity of Intravenously Administered FHD-609 in Subjects With Advanced Synovial Sarcoma or Advanced SMARCB1-Loss Tumors
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase 1 multicenter open-label dose escalation and expansion study is designed to assess the safety tolerability pharmacokinetics PK pharmacodynamics PD and preliminary clinical activity of FHD-609 given intravenously in subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors
Detailed Description:
This study is an ascending multiple dose clinical trial with expansion arms It is primarily intended to evaluate the safety and tolerability of FHD-609 when administered intravenously to subjects with advanced synovial sarcoma or advanced SMARCB1-loss tumors The Dose Escalation Phase will allow for the determination of the recommended phase 2 dose RP2D andor maximum tolerated dose MTD of FHD-609 This study will also evaluate the PKPD profiles of multiple dose administration of FHD-609
The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609 including toxicities that may occur less frequently and an assessment of anti-tumor activity The data from this study in subjects with advanced synovial sarcoma including safety tolerability PKPD findings and anti-tumor activity will form the basis for subsequent clinical development of FHD-609
The Dose Expansion Phase will allow a more robust evaluation of the safety profile of FHD-609 including toxicities that may occur less frequently and an assessment of anti-tumor activity The data from this study in subjects with advanced synovial sarcoma including safety tolerability PKPD findings and anti-tumor activity will form the basis for subsequent clinical development of FHD-609
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