This is an open-label Phase I/II trial of simmitinib plus SG001 in patients with advanced solid tumors. Phase I will determine and confirm the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) for simmitinib in combination with SG001 in patients with advanced solid tumors. Phase 2 (Expansion) will evaluate the safety and efficacy of the combination in 3 cohorts at the RP2D from Phase I.
Have fully understood and voluntarily sign the ICF for this study;
Age of 18-75 years (inclusive);
Dose escalation phase: patients with histologically or cytologically confirmed inoperable or metastatic advanced solid tumors;
Dose expansion phase: patients who have failed standard treatment (PD or intolerable toxicity after treatment), have no available standard treatment.According to the previous data, the specific tumor cohort was expanded.
Patients who have previously received any anti-tumor therapy within 4 weeks prior to the first dose;
Urine protein ≥ ++ and 24 h urine protein > 1.0g at screening period;
Symptomatic central nervous system (CNS) metastases or meningeal metastases;
Patients who have previously received any live attenuated vaccine within 4 weeks before the first use of the study treatment or are expected to received any live attenuated vaccine during the study;
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Treatment groupsSee each treatment group below.