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Clinical Trials in China / NCT05836948
Recruiting Phase 1

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

NCT05836948 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2023-05-18
Last updated
2025-08-11

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

SHR-9839

SHR-9839: Weekly fixed dose injection of SHR-9839

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Have at least one measurable tumor lesion per RECIST v1.1; 3. ECOG performance status of 0-1; 4. Life expectancy ≥ 12 weeks; 5. Adequate bone marrow and organ function; 6. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form. Exclusion Criteria: 1. Patients with active central nervous system metastases or meningeal metastases; 2. 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; 3. History of serious cardiovascular and cerebrovascular diseases; 4. 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; 5. Adverse reactions of previous anti-tumor treatment have not recovered to Grade ≤ 1 per NCI-CTCAE v5.0.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Tumor Hospital Hangzhou Zhejiang Recruiting

More Shanghai Hengrui Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05836948 on ClinicalTrials.gov ↗ ← All trials in China