A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors

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 above 18 years old, regardless of gender；
• The ECOG score is 0 or 1；
• Expected survival ≥12 weeks
• Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy；
• Provide archived or fresh tumor tissue；
• 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

• Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases；
• Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors；
• Systemic antitumor therapy was received 4 weeks before the start of the study；
• Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy >30 Gy within 6 months prior to initial administration；
• Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or exclusion criteria；
• Systemic immunosuppressive therapy was administered within 14 days prior to the first study；
• Subjects with known or suspected interstitial pneumonia；
• ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
• The presence of any active, known, or suspected autoimmune disease；
• Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；
• The presence of clinical cardiac symptoms or diseases that are not well controlled；
• Any other malignancy diagnosed within the previous 5 years；
• Subjects who had a severe infection within 28 days prior to the first dose；
• Active hepatitis B or active hepatitis C；
• Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；
• History of immune deficiency；
• Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；
• Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter；
• Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures；
• Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs；
• Female subjects who are pregnant or plan to become pregnant during the study period；
• The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；
• In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.