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Trial Title:
The Clinical Study of SHR-9839 for Injection in Patients With Advanced Solid Tumors
NCT ID:
NCT05836948
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-9839
Description:
Weekly fixed dose injection of SHR-9839
Arm group label:
SHR-9839
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Tumor Hospital
Address:
City:
Hangzhou
Zip:
310006
Country:
China
Contact:
Last name:
Xiangdong Cheng, Doctor
Phone:
+86-13968032995
Email:
Chengxd516@126.cm
Start date:
May 1, 2023
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05836948
