An open, multicenter, dose-exploring Phase I trial include Part A and Part B to evaluate the safety, tolerability and efficacy of APG-2449.
Part A: To evaluate the safety of APG-2449 monotherapy in patients with advanced solid tumors. Part B: To evaluate the safety, tolerability, and efficacy of APG-2449 combined with PLD in the treatment of ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGTreatment-related adverse events per NCI-CTCAE version 5.0.
The number and frequency of adverse events of test drug will be assessed according to CTCAE v5.0.
Time frame: Up to 1 year
Dose Limiting Toxicity(DLT).
DLT will be defined based on the rate of drug-related grade 3 to 5 adverse events experienced within the first 4 weeks of study treatment. These will be assessed per NCI-CTCAE version 5.0.
Time frame: Up to 28 days
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