Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors

This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.

Inclusion criteria

• Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements
• The age of signing the informed consent is from 18 to 75 years old, regardless of gender
• Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
• The ECOG score is 0 or 1
• Expected survival ≥12 weeks
• At least one measurable lesion according to RECIST v1.1 criteria
• Good level of organ function
• Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

Exclusion criteria

• subjects with uncontrolled or active brain metastasis；
• subjects with clinical significant lung disease;
• subjects with history of autoimmune diseases;
• Known active hepatitis B or C infection;
• Subjects with severe cardiovascular and cerebrovascular diseases
• Uncontrolled tumor-related pain
• Severe infections that require intravenous antibiotic, antiviral or antifungal control
• Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
• Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
• Known allergic to any compound of SHR-A2102 or HRS-4642
• Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment