Clinical Trial of the TQB2102 Injection in Patients With Advanced Cancers

NCT ID: NCT05735496

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 219 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-09
• Study Completion Date: 2027-07-31

Brief 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.

Conditions

Advanced Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB2102 injection

intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)

Group Type: EXPERIMENTAL

TQB2102 injection

Intervention Type: DRUG

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against HER2, a enzyme-cleavable linker, and a topoisomerase I inhibitor payload.

Interventions

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.

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fujian Cancer Hospital.

Fuzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital, Harbin, China

Harbin, Heilongjiang, China

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Fudan University shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Countries

China

Other Identifiers

TQB2102-I-01

Identifier Type: -

Identifier Source: org_study_id