RecruitingPhase 1NCT06115902

A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer

A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer

Sponsor

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

Enrollment

150 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an 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 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests TQB2102, a new drug, in patients with recurrent or metastatic breast cancer that expresses the HER2 protein. HER2 is a protein that drives the growth of some breast cancers, and targeting it is a key treatment strategy. **You may be eligible if:** - You are between 18 and 75 years old - You have breast cancer confirmed to express HER2 by pathology testing - Your cancer has come back locally or spread to other parts of the body and cannot be cured with surgery or radiation - Your cancer has progressed on prior HER2-targeted treatment - Your overall health is good (ECOG 0-1) - Your expected survival is at least 3 months **You may NOT be eligible if:** - Your cancer does not express HER2 - You have severe heart, liver, or kidney problems - You are pregnant or breastfeeding - You have active brain metastases that are untreated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTQB2102 for injection

TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

Locations(20)

Anhui Pronvincial Cancer Hospital

Hefei, Anhui, China

Lu'an People's Hospital

Lu'an, Anhui, China

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Hunan Cancer Hospital

Changsha, Hunan, China

Ganzhou People's Hospital

Ganzhou, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

Xi'an, Shannxi, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Suining Central Hospital

Suining, Sichuan, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06115902

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