This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.
Subjects must voluntarily participate in the study and sign an informed consent form;
Aged 18-75 years, male or female eligible；
ECOG performance status score of 0-1；
Expected survival ≥12 weeks；
History of other malignant tumors within the past 5 years；
Received systemic anti-tumor therapy within 4 weeks prior to the first study dose.
Surgical procedures requiring tracheal intubation and general anesthesia were performed within 4 weeks before the first administration, diagnostic or surface surgery was performed within 1 week before the first administration, or elective surgery was expected during the trial.
The study received radical radiotherapy within 4 weeks before the first medication ; and received palliative radiotherapy within 2 weeks before the first medication.
Single group
HRS-6719
DrugHRS-6719
Dose Limited Toxicity (DLT)
Maximum tolerable dose (MTD)
Recommended dose for phase II (RP2D)
Incidence and severity of AE
Relative bioavailability after meals on an empty stomach
ORR
DOR
DCR
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