Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2025-12-27 @ 5:46 PM
Study NCT ID:
NCT05866692
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TY-2699a in Patients With Locally Advanced or Metastatic Solid Tumors
Sponsor:
TYK Medicines, Inc
Organization:
Study Overview
Official Title:
A Phase I, Multicenter, Open-label Study of TY-2699a, Administered Orally in Adult Patients With Locally Advanced or Metastatic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2023-08
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 phase I, multicenter, open-label study. The study will investigate the safety, tolerability, PK, and preliminary efficacy of TY-2699a on locally advanced or metastatic solid tumors.
Detailed Description:
To assess the safety and tolerability of TY-2699a when administered as a single agent in subjects with locally advanced or metastatic solid tumors.
To determine the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) as a single agent in subjects with locally advanced or metastatic solid tumors.
To evaluate the pharmacokinetics (PK) of TY-2699a administered at single and multiple oral doses.
To assess the preliminary antitumor activity of TY-2699a as a single agent in subjects with locally advanced or metastatic solid tumors.
To determine the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) as a single agent in subjects with locally advanced or metastatic solid tumors.
To evaluate the pharmacokinetics (PK) of TY-2699a administered at single and multiple oral doses.
To assess the preliminary antitumor activity of TY-2699a as a single agent in subjects with locally advanced or metastatic solid tumors.
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?: