IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

Inclusion Criteria: 1. Written informed consent must be obtained before any study procedure is performed. 2. Men or women 18 years of age or older. 3. Histologically or cytologically confirmed advanced or recurrent malignant solid tumors that are metastatic or unresectable. (Subjects must submit tumor tissue sections from within the past 5 years for CCR8 expression testing. For subjects without paraffin-embedded tissues, a fine-needle aspiration biopsy may be performed. Subjects who cannot provide tumor tissue sections or undergo biopsy are only eligible for inclusion during the dose escalation phase. During the dose expansion phase, CCR8 positivity must be known or tumor tissue sections must be provided with confirmed CCR8 expression.) 4. Subjects must have failed or been intolerant to standard antitumor therapy, or lack a standard treatment regimen, or be deemed by the investigator as currently unsuitable for standard therapy. 5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. 6. Life expectancy ≥ 3 months. 7. Subjects must be able to swallow the oral investigational drug. 8. The ECOG performance status score is 0 or 1. 9. Sufficient hematologic and organ function, with the following laboratory test values: 1. Hematology: Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L; platelet count ≥ 75×10⁹/L; Hemoglobin ≥ 9 g/dL; lymphocytes ≥ 0.8×10⁹/L; 2. Renal: Creatinine clearance calculated by the Cockcroft-Gault method ≥ 50 mL/min or serum creatinine ≤ 1.5× upper limit of normal (ULN); 3. Hepatic: Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 3×ULN, or ≤ 5×ULN for subjects with liver metastases; total bilirubin ≤ 1.5×ULN, or ≤ 3×ULN for subjects with Gilbert syndrome or genetically equivalent conditions; 4. Coagulation: Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5× upper limit of normal (ULN). 10. Patients must be willing and able to comply with all scheduled visits, treatments, laboratory tests, and other study requirements. 11. Male and female participants of reproductive potential who engage in heterosexual sexual behavior must agree to use reliable contraceptive methods (hormonal, barrier, or abstinence,etc.) for at least 4 months during the trial period and after the last study drug administration (refer to Appendix 13.1 of the protocol) Exclusion Criteria: 1. Primary malignant tumors of the central nervous system or malignant tumors associated with human immunodeficiency virus (HIV) . 2. Previous use of CCR8-targeted therapy. 3. Received the following treatment within the specified time frame: 1. Planned major surgery within 4 weeks prior to the first dose administration (excluding minor procedures such as vascular access placement, gastrointestinal/biliary stent placement, or biopsy); 2. Immunotherapy or biological therapy administered within 28 days prior to the initial administration; 3. Chemotherapy \