The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer

NCT06452706 | Recruiting Phase 2

• 1 other identifier: TQB2102-II-02
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 16

Brief Summary

This study aims to evaluate the efficacy and safety of TQB2102 for injection in HER2 negative recurrent/metastatic breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate

  The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the RECIST 1.1.

  Up to 24 months after study start.

Secondary Outcomes (9)

• Progression-free survival

  Up to 36 months after study start

• Duration of disease remission

  Up to 24 months after study start

• Disease control rate

  Up to 24 months after study start

• Clinical benefit rate

  Up to 24 months after study start

• Overall survival

  Up to 48 months after study start

Study Arms (1)

TQB2102 for injection

EXPERIMENTAL

7.5mg/kg TQB2102, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.

Drug: TQB2102 for injection

Interventions

TQB2102 for injection DRUG

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

TQB2102 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participants voluntarily participate in the study and sign an informed consent form.
• Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) score: ≤1 point; Expected survival period exceeds 3 months.
• Breast cancer patients diagnosed as HER2 negative by pathology, with evidence of local recurrence or distant metastasis are not suitable for surgery or radiation therapy aimed at healing.
• Sufficient tumor tissue samples must be available for HER2 evaluation by pathologists at the main research center.
• The participants's previous treatment needs to meet the following criteria: failure after receiving at least first-line systemic chemotherapy during the recurrence /metastasis stage (for hormone receptor positive participants, failure after receiving cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors combined with endocrine therapy during the recurrence/metastasis stage.
• There exists disease progression or intolerance during or after the most recent treatment before enrollment.
• According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, there should be at least one measurable lesion.
• The main organ functions well and meets certain standards.
• Female participants of childbearing age should agree to use contraceptive measures during the study period and within 6 months after the end of the study; within 7 days prior to enrollment, the serum pregnancy test was negative and must be a non lactating subject; male participants should agree to adopt avoidance measures during the study period and within 6 months after the end of the study period.

You may not qualify if:

• Concomitant diseases and medical history:
• Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;
• Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;
• Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;
• Long term unhealed wounds or fractures;
• Participants who have a history of interstitial lung disease/pneumonia (non infectious) requiring steroid intervention treatment in the past, or currently have interstitial lung disease/pneumonia, or whose screening imaging suggests suspected interstitial lung disease/pneumonia and cannot be ruled out;
• An arterial/venous thrombotic event occurred within 6 months prior to the first medication use;
• Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;
• Subjects with any severe and/or uncontrolled diseases. Rheumatoid arthritis with joint function activity graded as Grade IV or requiring wheelchair or bed rest.
• Tumor related symptoms and treatment:
• Participants who have received other anti-tumor drug treatments such as chemotherapy, curative radiotherapy, or immunotherapy within 4 weeks before the first medication, or who are still within the 5 half-lives of the drug (whichever is the shortest); Participants who have previously received local radiotherapy;
• Received endocrine therapy or traditional Chinese patent medicines and simple preparations with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug directions within 2 weeks before the first drug use;
• Imaging shows that the tumor has invaded important blood vessels, or the researcher determines that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during subsequent studies;
• Uncontrollable pleural effusion, ascites, and moderate or higher amounts of pericardial effusion that require repeated drainage;
• Known presence of cancerous meningitis or clinically active central nervous system metastasis;

Sponsors & Collaborators

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

Study Sites (16)

Bozhou People's Hospital

Bozhou, Anhui, 236804, China

NOT YET RECRUITING

Chuzhou First People's Hospital

Chuzhou, Anhui, 239001, China

NOT YET RECRUITING

Anhui Provincial Public Health Clinical Center

Hefei, Anhui, 230031, China

NOT YET RECRUITING

Ma'anshan People's Hospital

Ma’anshan, Anhui, 243000, China

NOT YET RECRUITING

Wuhu Hospital Affiliated to East China Normal University

Wuhu, Anhui, 241399, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The Third People's Hospital of Zhengzhou

Zhengzhou, Henan, 450000, China

NOT YET RECRUITING

The First People's Hospital of Zhengzhou

Zhengzhou, Henan, 450003, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

NOT YET RECRUITING

The First People's Hospital of Changde City

Changde, Hunan, 415003, China

NOT YET RECRUITING

Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

NOT YET RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

NOT YET RECRUITING

Cancer Hospital Affiliated to Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

NOT YET RECRUITING

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310014, China

NOT YET RECRUITING

Suzhou Municipal Hospital

Suzhou, Zhejiang, 234099, China

NOT YET RECRUITING

Wenzhou Medical University Affiliated First Hospital

Wenzhou, Zhejiang, 325015, China

NOT YET RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Injections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Kunwei Shen, Doctor

CONTACT

13916612760; kwshen@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 11, 2024
• Study Start: November 14, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 19, 2024

Record last verified: 2024-04

Locations

CN (16)