The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

About this trial

This study is an open-label, phase I clinical trial of SHR-9839 in patients with advanced solid tumors. The whole study is divided into three stages: dose escalation, dose expansion and efficacy expansion.

Eligibility criteria

Qualifiers

Patients 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 status of 0-1;

Life expectancy ≥ 12 weeks;

Disqualifiers

Patients with active central nervous system metastases or meningeal metastases;

Received anti-tumor treatment such as chemotherapy, biotherapy, targeted therapy, immunotherapy, radical radiotherapy, or other unlisted clinical research drugs or treatments within 4 weeks prior to the first use of the study drug;

History of serious cardiovascular and cerebrovascular diseases;

Subjects who received>30Gy of radiation therapy within 4 weeks before the first medication, and those who received ≤ 30Gy of palliative radiation therapy within 7 days before the first medication;

Trial design

Treatments tested in this trial

  • SHR-9839

Treatment groups

174 Participants
are divided into 1 treatment group