Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

• Status: Not yet recruiting
• Trial end date: 2024-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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.