A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.

About this trial

This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.

Eligibility criteria

Qualifiers

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;

Subjects with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors which is relapsed or refractory to standard treatment, or lack of standard treatment, or standard treatment is not applicable currently;

Have at least one measurable tumor lesion per RECIST v1.1;

ECOG performance score of 0-1;

Disqualifiers

Subjects with active central nervous system metastases or meningeal metastases;

History of serious cardiovascular and cerebrovascular diseases;

Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;

Severe infection within 4 weeks prior to the first dose;

Trial design

Treatments tested in this trial

  • SHR-1681

Treatment groups

300 Participants
are divided into 1 treatment group