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

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.

NCT Number	NCT07363967
Lead Sponsor	Beijing StoneWise Technology Co., Ltd Collaborators: Shanghai East Hospital, Shanghai Cancer Centre, Zhejiang Cancer Hospital
Conditions	Solid Tumor Malignancies
Enrollment	60 participants
Start Date	2025-06-13
Primary Completion	2027-09-01 (estimated)
Study Completion	2028-02-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-23