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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: TQB2102 for injection

• Study Type: Interventional
• Enrollment (Actual): 153
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Anhui Pronvincial Cancer Hospital
    • Lu'an, Anhui, China, 237008
      • Lu'an People's Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Chongqing University Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Cancer Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Hunan
    • Changsha, Hunan, China, 410031
      • Hunan Cancer Hospital
  • Jiangxi
    • Ganzhou, Jiangxi, China, 341000
      • Ganzhou People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130012
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • The First Hospital of China Medical University
    • Shenyang, Liaoning, China, 110000
      • Liaoning Cancer Hospital & Institute
  • Shandong
    • Jinan, Shandong, China, 250117
      • Cancer Hospital Affiliated to Shandong First Medical University
    • Linyi, Shandong, China, 276034
      • Linyi Cancer Hospital
  • Shannxi
    • Xi'an, Shannxi, China, 710089
      • The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Shanxi Cancer Hospital
  • Sichuan
    • Suining, Sichuan, China, 629000
      • Suining Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300202
      • Tianjin Medical University Cancer Institute & Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB2102 for injection; Dose: 6.0 mg/kg or 7.5 mg/kg of TQB2102 for injection. Administration: Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.	Drug: TQB2102 for injection; TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).	Baseline up to 10 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.	Baseline up to 14 months.
Duration of Remission (DOR)	DOR defined as the time when the participants first achieved complete or partial remission to disease progression.	Baseline up to 14 months.
Disease Control Rate (DCR)	Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).	Baseline up to 10 months.
Clinical Benefit Rate (CBR)	Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for ≥ 24 weeks.	Baseline up to 14 months.
Overall Survival (OS)	OS defined as the time from the first injection to death from any cause.	Baseline up to 20 months.
Incidence of adverse event (AE)	The occurrence of all adverse medical events after the first injection.	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Severity of adverse event (AE)	The severity of all adverse medical events after the first injection.	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Concentration of TQB2102	Serum concentration of TQB2102	0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
Concentration of total antibody	Total antibody concentration in serum	0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
Small molecule toxin	Small molecule toxin in plasma	0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
Anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA)	Before infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, 30 days after the end of the last infusion. Each cycle is 21 days.

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2023
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: October 30, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 8, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: TQB2102-Ib-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No