Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769075
Status:
RECRUITING
Last Update Posted:
2023-04-24
First Post:
2023-02-09
Brief Title:
A Study of TY-2136b in Patients With Advanced Solid Tumors Harboring ALK ROS1 or NTRK1-3 Alterations
Sponsor:
TYK Medicines Inc
Organization:
TYK Medicines Inc
Study Overview
Official Title:
A Phase I Multicenter Open-label Study of TY-2136b Administered Orally in Patients With Advanced or Metastatic Solid Tumors Harboring ALK ROS1 or NTRK1-3 Alterations
Status:
RECRUITING
Status Verified Date:
2023-04
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 primary objective of this study is to evaluate the safety and tolerability of TY-2136b and to determine the recommended phase 2 dose RP2D with dose-escalation stage and dose-expansion stage
Detailed Description:
To evaluate the pharmacokinetic PK characteristics of TY-2136b after single and multiple oral doses
To assess preliminary antitumor activity of TY-2136b as a single agent when administered orally to patients with advanced or metastatic solid tumors
To identify mutations in the ALK ROS1 and NTRK1-3 or other molecular alterations in blood or tumor tissues associated with clinical outcome
To assess preliminary antitumor activity of TY-2136b as a single agent when administered orally to patients with advanced or metastatic solid tumors
To identify mutations in the ALK ROS1 and NTRK1-3 or other molecular alterations in blood or tumor tissues associated with clinical outcome
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