Phase I/II Clinical Trials of SHR-8203 Injection in Participants With Advanced Solid Tumors

An Open-label, Multi-center Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-8203 Injection in Participants With Advanced Solid Tumors

This trial is a multicenter, open-label Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and efficacy of SHR-8203 injection in participants with advanced solid tumors.

Inclusion Criteria:

1. Age between 18 and 75 years old, gender not limited;
2. Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.
3. Participants with advanced or metastatic solid tumors confirmed by histological or cytological pathology who have failed standard treatment (disease progression or toxic intolerance) or have no effective standard treatment;
4. Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.
5. Have at least one measurable lesion as per RECIST v1.1;
6. ECOG PS score: 0-1;
7. Good organ function level.

Exclusion Criteria:

1. Imaging studies show that the tumor invades major blood vessels or has an unclear boundary with blood vessels, and researchers determine that there is a risk of massive hemorrhage;
2. Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;
3. Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;
4. Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;
5. Participants who have experienced severe infections within one month prior to the first medication.