A Phase I/II of HRS-6719 in Patients With Advanced/Metastatic Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must voluntarily participate in the study and sign an informed consent form; 2. Aged 18-75 years, male or female eligible； 3. ECOG performance status score of 0-1； 4. Expected survival ≥12 weeks； 5. Patients with histologically or cytologically confirmed advanced malignant solid tumors who meet one of the following criteria:Disease progression or intolerance after receiving adequate standard therapy; Lack of standard treatment options;Currently ineligible for standard therapy； 6. Ability to provide sufficient fresh or archived tumor tissue specimens； 7. Adequate function of vital organs； 8. Effective contraception must be used during the trial. For women of childbearing potential, a negative pregnancy test within 7 days prior to the first dose is required。 Exclusion Criteria: 1. History of other malignant tumors within the past 5 years； 2. Received systemic anti-tumor therapy within 4 weeks prior to the first study dose. 3. Surgical procedures requiring