Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 1
Started
2023-03-09
Last updated
2025-08-01
Condition(s) studied
Advanced Cancer
Investigational drug(s) / intervention(s)
TQB2102 injection
TQB2102 injection: TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 tumo;
* 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.
Primary outcome measure(s)
Dose Limiting Toxicity (DLT) — During the first treatment cycle (21 days). DLT was defined as toxicities that meet pre-defined severity criteria (according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred within the first cycle (21 days) of treatment.
Maximum tolerated dose (MTD) — During the first treatment cycle (21 days). MTD was defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
The occurrence rate of all adverse events (AEs) — From date of the first dose until 28 days after last dose or new anti-tumor treatment, whichever came first. The occurrence of adverse events defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0)
Dose escalation: recommended phase 2 dose (RP2D) — Up to 2 years The RP2D of DT-9081 is determined using pharmacokinetics, pharmacodynamics and safety data of the dose escalation part of the study.
Trial sites (12)
Facility
City
Region
Status
Fujian Cancer Hospital.
Fuzhou
Fujian
Sun Yat-sen University Cancer Center
Guangzhou
Guangdong
Harbin Medical University Cancer Hospital, Harbin, China
Harbin
Heilongjiang
The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou
Henan
Hunan Cancer Hospital
Changsha
Hunan
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Jiangsu
The First Hospital of China Medical University
Shenyang
Liaoning
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Shaanxi
Fudan University shanghai Cancer Center
Shanghai
Shanghai Municipality
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
Shanghai
Shanghai Municipality
West China Hospital, Sichuan University
Chengdu
Sichuan
Mianyang Central Hospital
Mianyang
Sichuan
More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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