RecruitingPhase 1NCT05836948

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

An Open-label, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-9839 for Injection in Patients With Advanced Solid Tumors

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Enrollment

174 participants

Start Date

May 18, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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;
Adequate bone marrow and organ function;
Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Exclusion Criteria5

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;
Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

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