A Phase I/IIa Study of AL8326 Combined With Toripalimab in the Treatment of Advanced Solid Tumors.
Trial Parameters
Brief Summary
This trial is an open, non-randomized, phase I/IIa clinical trial, which will evaluate the preliminary effectiveness and safety of AL8326 tablets in patients with advanced solid tumors
Eligibility Criteria
Inclusion Criteria 1. Subjects must be able to understand and voluntarily sign a written informed consent form prior to the initiation of any study-related procedures. 2. Age ≥ 18 years. 3. Subjects with histologically confirmed advanced recurrent or metastatic solid tumors who meet one of the following conditions: 1. Failure of standard therapy (disease progression after treatment or intolerance to treatment toxicity); 2. no effective treatment available. 3. Toripalimab monotherapy as a second-line or later standard treatment. 4. Must have at least one measurable lesion as defined by RECIST 1.1. 5. Prior cytotoxic chemotherapy must have been completed at least 4 weeks before enrollment, and any toxicities must have recovered to ≤ Grade 1 (except alopecia). 6. Life expectancy of ≥ 12 weeks at the time of enrollment. 7. ECOG performance status of 0 or 1. 8. Adequate organ function: 1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L (1500/mm³); Platelets ≥ 100 × 10⁹/L