Treatment for recurrent or metastatic breast cancer using TQB2102

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

This study is testing a new drug called TQB2102 to see if it can help people with recurrent or metastatic breast cancer by targeting specific cancer cells.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 20 sites (Hefei, Anhui and 19 other locations)
• Trial ID: NCT06115902 on ClinicalTrials.gov

What this trial studies

This study evaluates TQB2102, an antibody-drug conjugate designed to target HER2-expressing breast cancer cells. It aims to assess the drug's effectiveness, safety, pharmacokinetics, and the presence of anti-drug antibodies in patients with recurrent or metastatic breast cancer. Participants will receive TQB2102 injections and will be monitored for treatment response and side effects. The study is in Phase 1, focusing on establishing initial safety and efficacy data.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with HER2-expressing breast cancer that has recurred or metastasized and who have not responded to previous treatments.

Not a fit: Patients with early-stage breast cancer or those who have not expressed HER2 may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new targeted therapy option for patients with HER2-positive recurrent or metastatic breast cancer.

How similar studies have performed: Other studies involving antibody-drug conjugates for HER2-positive breast cancer have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 19 other locations

• Anhui Pronvincial Cancer Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Lu'an People's Hospital — Lu'an, Anhui, China (NOT_YET_RECRUITING)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (NOT_YET_RECRUITING)
• Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• Jiangmen Central Hospital — Jiangmen, Guangdong, China (NOT_YET_RECRUITING)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Ganzhou People's Hospital — Ganzhou, Jiangxi, China (NOT_YET_RECRUITING)
• Jilin Cancer Hospital — Changchun, Jilin, China (NOT_YET_RECRUITING)
• Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Cancer Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (NOT_YET_RECRUITING)
• Linyi Cancer Hospital — Linyi, Shandong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine — Xi'an, Shannxi, China (NOT_YET_RECRUITING)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Suining Central Hospital — Suining, Sichuan, China (NOT_YET_RECRUITING)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (NOT_YET_RECRUITING)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Qingyuan Zhang, Doctor

Conditions: Breast Cancer