Status:
UNKNOWN
Clinical Trial of the TQB2930 Injection in Patients With Advanced Cancers
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions:
Advanced Cancers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
TQB2930 is an anti-HER2 (Human Epidermal Growth Factor Receptor 2) bispecific antibody that can simultaneously bind two epitopes of HER2, leading to a dual HER2 signal blockage. This is a phase I stud...
Eligibility Criteria
Inclusion
- 1 Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- 2 Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, and life expectancy ≥12 weeks;
- 3 Histologically or cytologically confirmed, locally advanced tumors, Priority will be given to subjects with HER2 positive solid tumor;
- 4 Malignant tumor that failed from standard treatment or had no standard treatment;
- 5 According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
- 6 The main organs function well;
- 7 Male or female patient had no plans to become pregnant and voluntarily took effective contraceptive measures from agree with the study to at least 6 months after the last dose of study drug.
Exclusion
- 1 Concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years;
- 2 History of uncontrolled intercurrent illness;
- 3 Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4 weeks prior to first dose;
- 4 Patients with known symptomatic brain metastases;
- 5 Receiving any other investigational agent within 4 weeks before first dose;
- 6 Unstable or serious concurrent medical conditions, as assessed by the Investigators, that would substantially increase the risk-benefit ratio of participating in the study.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05380882
Start Date
May 1 2022
End Date
December 1 2023
Last Update
May 19 2022
Active Locations (1)
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1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060