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

ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Suncadia Pharmaceuticals Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 75 years old, gender not limited;

Be willing to participate and abide by the requirements of the research protocol, and be willing to cooperate with the follow-up.

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;

Able to provide sufficient fresh or archived tumor tissue specimens for the third-party central laboratory designated by the sponsor.

Disqualifiers

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;

Suffering from hypertension and unable to achieve good control through antihypertensive drug treatment;

Pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, poorly controlled, or moderate to severe;

Major arterial or venous thrombosis events occurred within 6 months before the first administration of medication;

Trial design

Treatments tested in this trial

  • SHR-8203 Injection

Treatment groups

200 Participants
are divided into 1 treatment group