This trial is an open-label, multi-center, dose escalation, dose expansion, and cohort expansion phase I/II clinical study of SYHX1903 in patients with relapsed/refractory hematologic malignancies. This trial aims to evaluate the safety, tolerance, pharmacokinetics, and preliminary antitumor activity of SYHX1903 in patients with relapsed/refractory hematologic malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
312
SYHX1903 tablets, orally, qd
Dose limiting toxicities
DLTs will be determined from monitoring adverse events (AEs), and abnormal laboratory tests (clinical chemistry, hematology, and urinalysis), physical examinations, vital signs (blood pressure and pulse), and electrocardiogram (ECG).
Time frame: 28 days
Incidence of adverse events
Number of subjects with adverse events as a measure of safety and tolerability including changes in vital signs, electrocardiograms (ECGs), safety and laboratory parameters
Time frame: 1 year
Antitumor activity of SYHX1903 in patients by assessing overall response rate (ORR)
To assess proportion of patients with anti tumor response to SYHX1903. response assessment by Cheson (2014) criteria and myeloma (Palumbo 2014) Response will be evaluated every 4-12 weeks (based on disease type) until progression
Time frame: 1 year
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