Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:56 PM
Study NCT ID:
NCT04433494
Status:
UNKNOWN
Last Update Posted:
2022-12-07
First Post:
2020-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TY-302 in Patients With Advanced Solid Tumors
Sponsor:
TYK Medicines, Inc
Organization:
Study Overview
Official Title:
A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of TY-302 Capsules in Patients With Advanced Solid Tumors in China
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
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-302 single and the combination with Tamoxifen in dose-escalation and dose-expansion study.The drugs involved in this study are:
* TY-302
* Tamoxifen
* TY-302
* Tamoxifen
Detailed Description:
This is an open-label, single-arm, phase I trial. The purpose of this study is to :
* Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen
* Determine the response rate of the combination
* Further evaluate the safety and side effect profile for the combination of TY-302 and Tamoxifen.
* Test a safe and tolerable dose of TY-302 single and the combination with Tamoxifen
* Determine the response rate of the combination
* Further evaluate the safety and side effect profile for the combination of TY-302 and Tamoxifen.
Study Oversight
Has Oversight DMC:
False
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?: