Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

CTTQ

Status and phase

Active, not recruiting

Phase 1

Conditions

Advanced Cancer

Treatments

Drug: TQB2102 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05735496

TQB2102-I-01

Details and patient eligibility

About

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.

Enrollment

219 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.