Clinical Trials in China / NCT05735496
Active, not recruiting
Phase 1
Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers
NCT05735496 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Cancer
Investigational drug(s) / intervention(s)
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
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 |
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Official registry record
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.
View NCT05735496 on ClinicalTrials.gov ↗ ← All trials in China