Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers

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.

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.