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.
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.
Subjects aged between 18 to 75 years old, male or female when signing the informed consent form (ICF).
Tumor tissue samples (preferable but not mandatory; fresh or archived) from patients will be collected during the screening period to assay the expression of HPK1. However, patient enrollment is not based on HPK1 expression levels.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Known to be allergic to SWA1211 tablets or any of their excipients (Polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer; Vitamin E polyethylene glycol succinate, VE-TPGS 1000; Hypromellose; Propyl gallate; Methanol; Dichloromethane; Sodium lauryl sulfate; Microcrystalline cellulose; Manitol; Crospovidon; Silicon dioxide; Sodium stearyl fumarate; Film coating premix (Gastric dissolve type)).
Prior treatment with hematopoietic progenitor cell kinase 1 (HPK1) inhibitors.
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent).
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption.
Beijing StoneWise Technology Co., Ltd
Lead sponsor
Shanghai East Hospital
Collaborator
Shanghai Cancer Centre
Collaborator
Zhejiang Cancer Hospital
Collaborator