To hear about similar clinical trials, please enter your email below
Trial Title:
A Trial of SHR-7367 in Subjects With Advanced Solid Tumors
NCT ID:
NCT05740202
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
Intervention model description:
The study was divided into three phases, the dose escalation phase and the dose extension
phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant
tumors.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-7367
Description:
The study was divided into three phases, the dose escalation phase and the dose extension
phase and therapeutic effect extension of SHR-7367 in subjects with advanced malignant
tumors.
Arm group label:
SHR-7367
Summary:
This is a dose-escalation and dose-expansion Phase 1 trial to evaluate the safety and
tolerability of SHR-7367 in subjects with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand and voluntarily agrees to participate by giving written
informed consent for the study;
2. Male or female aged ≥18 years and ≤75 years at the time of signing the ICF;
3. Histopathologically or cytologically documented advanced or metastatic malignancies;
4. At least 1 measurable lesion conforming to RECIST 1.1 criteria;
5. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or
1;
6. Female and male patients of reproductive potential must agree to use highly
effective contraception.
Exclusion Criteria:
1. Any immunostimulants administered within 4 weeks;
2. Systemic anti-tumor therapy within 4 weeks;
3. Any investigational cancer therapy administered within 4 weeks;
4. Surgical procedures requiring general anesthesia within 4 weeks;
5. History of autoimmune diseases;
6. History of immunodeficiency;
7. Severe infections within 2 weeks prior to the first study treatment;
8. Clinically significant cardiovascular condition;
9. Prior malignancy (other than current malignant tumor) within 5 ears before the first
dose of study treatment;
10. Known history of serious allergic reactions to the investigational product or its
main ingredients.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute and Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jihui Hao
Email:
Principal Investigator
Start date:
March 6, 2023
Completion date:
November 30, 2025
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/NCT05740202
