Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:54 AM
Study NCT ID:
NCT07363967
Status:
RECRUITING
Last Update Posted:
2026-01-23
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors
Sponsor:
Beijing StoneWise Technology Co., Ltd
Organization:
Study Overview
Official Title:
A Phase I First-in-Human Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of SWA1211 Tablets in Subjects With Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this phase I, first-in-human, open-label study is to evaluate the safety, tolerability, PK, and preliminary anti-tumor activity of SWA1211 in subjects with advanced solid tumors. It includes a Phase Ia dose escalation study and a Phase Ib dose expansion study. The main questions it aims to answer are:
1. Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors.
2. Identify the dose-limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase II dose (RP2D) of SWA1211.
3. Assess the PK characteristics of SWA1211.
4. Evaluate the preliminary anti-tumor activity of SWA1211.
1. Assess the safety and tolerability of SWA1211 in subjects with advanced solid tumors.
2. Identify the dose-limiting toxicity (DLT) to establish the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase II dose (RP2D) of SWA1211.
3. Assess the PK characteristics of SWA1211.
4. Evaluate the preliminary anti-tumor activity of SWA1211.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: