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Trial Title:
The Clinical Study of SHR-7631 for Injection in Patients With Advanced Solid Tumors
NCT ID:
NCT06381050
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
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-7631
Description:
The total dosage of SHR-7631 was calculated according to the weight weighing results of
the subjects before each administration, and was administered by intravenous drip.
Arm group label:
SHR-7631
Summary:
This study is an open-label, phase I clinical trial of SHR-7631 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 (subject with only
non-target tumor lesion will be permitted if he/she is planned to participant in
dose escalation stage or with mCRPC);
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.
7. Age 18 to 75 years old (including both ends), gender is not limited;
Exclusion Criteria:
1. Patients with active central nervous system metastases or meningeal metastases;
2. Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of
study drug;
3. Prior treatment with antibody-drug conjugate (ADC) consisting of topoisomerase I
inhibitors;
4. History of serious cardiovascular and cerebrovascular diseases;
5. Severe infection within 4 weeks prior to the first dose;
6. 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:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiping Li, Doctor
Phone:
+86-010-88121122
Email:
Huipingli2012@hotmail.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusen Wang, Doctor
Phone:
+86-020-87343009
Email:
wangshs@sysucc.org.cn
Start date:
May 24, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06381050
