Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05732831
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-01-30
Brief Title:
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Sponsor:
Tango Therapeutics Inc
Organization:
Tango Therapeutics Inc
Study Overview
Official Title:
A Phase 12 Multi-Center Open-Label Study to Evaluate the Safety Tolerability and Preliminary Anti-tumor Activity of TNG462 in Patients With MTAP-deleted Advanced or Metastatic Solid Tumors
Status:
RECRUITING
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 a first in human study in patients with advanced or metastatic solid tumors known to have an MTAP deletion The first part of the study is an open-label dose escalation and the second part is an open label dose expansion in specific MTAP-deleted tumor types The study drug TNG462 is a selective PRMT5 inhibitor administered orally The study is planned to treat up to 159 participants
Detailed Description:
This is a Phase 12 multi-center open label study in solid tumor patients who have a confirmed homozygous MTAP deletion in their tumor The Phase 1 portion is a dose escalation study of oral TNG462 in patients with confirmed MTAP-deleted solid tumors In Phase 2 5 expansion arms defined by confirmed MTAP-deleted tumor types will enroll in parallel at the RP2D of TNG462 In both parts of the study participants who tolerate the drug may continue treatment until disease progression
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