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
Trial Parameters
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects who are fully informed of the purpose, nature, method, and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent document before any study procedure. 2. Subjects aged between 18 to 75 years old, male or female when signing the informed consent form (ICF). 3. Study population: Phase Ia (Dose Escalation Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present. Phase Ib (Dose Expansion Study): Subjects with histologically or cytologically confirmed advanced solid tumors, who have failed standard treatments, have no available standard treatment, or are not suitable for standard treatment at present. The specific tumor types will be adjusted based on the results of Phase Ⅰa (dose escalation study). 4. Tumor tissue samples (preferable but not m