drugset / Trial / NCT07363967
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
Phase 1
Recruiting
60 enrolled
Beijing StoneWise Technology Co., Ltd
Shanghai Cancer Centre · collabShanghai East Hospital · collabZhejiang Cancer Hospital · collab
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-06-13
- Primary completion
- 2027-09-01
- Completion
- 2028-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SWA1211 | Unknown | — | Oral |
Indications
No indication recorded.