Smart drug delivers chemo directly to HER2 breast cancer cells

NCT ID NCT06115902

Disease control Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This trial tests an experimental drug called TQB2102 for people with HER2-positive breast cancer that has returned or spread to other parts of the body. TQB2102 is an antibody-drug conjugate—a targeted therapy that binds to HER2 on cancer cells and releases a potent chemotherapy directly inside them. The study aims to see if the drug can shrink tumors and how safe it is. Participants must have HER2-expressing breast cancer that is not curable with surgery or radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: TQB2102 (antibody-drug conjugate targeting HER2)
What this could lead to: If successful, TQB2102 could offer a new treatment option for people with HER2-positive breast cancer that has returned or spread.
What could go wrong: This is an early-phase trial, so the drug may not shrink tumors or may cause side effects. It is too soon to know if it will be better than existing therapies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

153 people

The number who actually took part.

Started

Nov 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects voluntarily participate in this study and sign informed consent; * Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months; * Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure; * Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials; * At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1); * The main organs function are normally; * Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period. Exclusion Criteria: * Concomitant disease and medical history: 1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug; 2. Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss); 3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment; 4. Long-term unhealed wounds or fractures; 5. Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out; 6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication; 7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 8. Patients with any severe and/or uncontrolled disease; * Tumor related symptoms and treatment: 1. Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug; 2. Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment; 3. Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding; 4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage; 5. Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded; 6. Patients with severe bone injury due to tumor bone metastasis; * Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products; * Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication; * In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.

Get updates

Get notified about this study

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

Anhui Pronvincial Cancer Hospital

Hefei, Anhui, 230000, China
Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250117, China
Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China
Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China
Ganzhou People's Hospital

Ganzhou, Jiangxi, 341000, China
Guangxi Medical University Cancer Hospital

Nanning, Guangxi, 530021, China
Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China
Hunan Cancer Hospital

Changsha, Hunan, 410031, China
Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China
Jilin Cancer Hospital

Changchun, Jilin, 130012, China
Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110000, China
Linyi Cancer Hospital

Linyi, Shandong, 276034, China
Lu'an People's Hospital

Lu'an, Anhui, 237008, China
Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China
Suining Central Hospital

Suining, Sichuan, 629000, China
Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

Xi'an, Shannxi, 710089, China
The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China
Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China
Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.