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Trial Title:
Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers
NCT ID:
NCT05735496
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2102 injection
Description:
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a
enzyme-cleavable linker, and a topoisomerase I inhibitor payload.
Arm group label:
TQB2102 injection
Summary:
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human
Epidermal Growth Factor Receptor 2 (HER2), a enzyme-cleavable linker, and a topoisomerase
I inhibitor payload, which combine the ability of antibodies to specifically target
tumour cells with the highly potent killing activity of drugs with payloads too toxic for
systemic administration. This is a phase I study to evaluate the safety, tolerability and
effectiveness of TQB102 injection in subjects with advanced malignancies.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study;
- 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;
- Histologically or cytologically confirmed, locally advanced tumors, Priority will be
given to subjects with HER2 positive solid tumor;
- Malignant tumor that failed from standard treatment or had no standard treatment;
- According to the RECIST 1.1 standard, patient with at least one evaluable lesion;
- The main organs function well;
- 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 Criteria:
- Concurrent secondary malignancy or other malignancy with no evidence of disease for
more than 3 years;
- History of uncontrolled intercurrent illness;
- Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4
weeks prior to first dose;
- Patients with known symptomatic brain metastases;
- Receiving any other investigational agent within 4 weeks before first dose;
- Patients with severe hypersensitivity after the use of monoclonal antibodies
- History of interstitial lung disease or pneumonia;
- Unstable or serious concurrent medical conditions, as assessed by the Investigators,
that would substantially increase the risk-benefit ratio of participating in the
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Contact:
Last name:
Ruihua Xu, Doctor
Phone:
+86-20-87343468
Email:
ruihxu@163.com
Start date:
February 2023
Completion date:
October 2024
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05735496
