This is a randomized, Open-label, Phase Ib/IIa study to evaluate the efficacy and safety of SPH4336 monotherapy or in combination with Cadonilimab in the patients with selected advanced solid tumors.
Subjects voluntarily participate in this study and sign informed consent.
Expected survival ≥3 months.
Patients with advanced solid tumors (including advanced Well differentiated/dedifferentiated liposarcoma) who cannot be treated by radical surgery/other local treatment.
According to RECIST v1.1, participants in the dose expansion phase must have at least one measurable lesion.
Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.
Had undergone surgery prior to treatment and hasn't yet recovered from adverse effects of surgery.
Had a history of other malignancies before starting the study.
History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA Class ≥II; QTcF≥ 470 ms; LVEF≤ 50%.
Parallel
SPH4336
DrugSPH4336 Tablets ：Orally, 400mg once a day ; 28 days/cycle
Cadonilimab
DrugIntravenous infusion, 6mg/Kg,28 days/cycle
Progression-free survival (PFS)
From the start date of study treatment to the date of progression disease or death , whichever occurred first.
Objective response rate (ORR)
Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
progression-free rate（PFR）
Proportion of subjects who were alive and free of disease progression from the first use of the investigational drug to 12 weeks.
Cmax
PK (Pharmacokinetics) parameters.
Tmax
PK (Pharmacokinetics) parameters.
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