Overview
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.
Eligibility
Inclusion Criteria:
- 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.
- The laboratory test results meet the organ function requirements before starting the study treatment.
- Prior to the start of the study treatment, the peripheral nerve toxicity of previous anti-tumor drug treatment had returned to ≤ grade 2, and other reversible toxic reactions had returned to ≤ grade 1, but hair loss/pigmentation and other effects were assessed by the investigator as beneficial to the subjects receiving the study treatment. The toxicity of the risk is not subject to this limitation.
- Subjects agree to use effective contraception from the time they sign the informed consent to the last time they use the study drug.
Exclusion Criteria:
- 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%.
- Diseases affecting drug administration or gastrointestinal absorption before the start of the study and assessed by the investigators could not be included in the study.
- Previous history of organ transplantation.
- Before starting the study, HBsAg positive patients with HBV DNA > 500IU/ mL or 2500 copies /mL or the lower limit of the study center detection, or HCV antibody positive patients with HCV RNA positive, or known HIV-infected patients, or known active tuberculosis.
- Accompanied by any other serious, progressive, or uncontrolled disease.
- Subjects with a known history of immune-related adverse events that the investigator determined could not be included.
- History of severe allergic disease, history of severe drug allergy, or known allergy to any component of the investigational product.
- Women who are pregnant or breastfeeding.
- Any other reason for which patients are ineligible for the study as assessed by the investigator.