A Study of SIGX1094R in Patients With Advanced Solid Tumors
Trial Parameters
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Brief Summary
This is a phase I clinical, first-in-human study of SIGX1094R monotherapy. The goal of this trial is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), anti-tumor activity and food effect of SIGX1094R in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following criteria before being enrolled in the study. 1. Patients must be able to understand the procedures and methods of this clinical study, voluntarily participate in the study and sign the ICF. 2. Patients aged ≥18 years when signing the ICF, male or female. 3. Patients with histologically, cytologically, or clinically proven advanced solid tumors (locally advanced or metastatic) that do not have standard treatment available, have disease progression on/after standard treatment, or cannot tolerate standard treatment. 4. Patients with at least one evaluable tumor lesion according to the RECIST v1.1; patients who have no measurable lesions but have evaluable lesions are allowed to be enrolled as judged by the investigator. 5. Patients (according to patients' option) will provide a pre-treatment tumor specimen (archival or fresh biopsy samples). If a fresh biopsy is required, procedures more invasive than a core biopsy or significant