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

Breast Cancer Clinical Trial

Official title:

The Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection in Human Epidermal Growth Factor Receptor 2 (HER2) Negative Recurrent/Metastatic Breast Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452706
• Other study ID #: TQB2102-II-02
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2024
• Est. completion date: June 2028

Study information

• Verified date: April 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Kunwei Shen, Doctor
• Phone: 13916612760
• Email: kwshen[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: June 2028
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Concomitant diseases and medical history:

1. Have experienced or currently suffer from other malignant tumors within 5 years prior to the first medication use;

2. Uncontrollable toxic reactions above CTCAE level 1 caused by any previous treatment;

3. Received significant surgical treatment or significant traumatic injury within 28 days prior to the first medication use;

4. Long term unhealed wounds or fractures;

5. 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;

6. An arterial/venous thrombotic event occurred within 6 months prior to the first medication use;

7. Individuals with a history of psychiatric drug abuse who are unable to quit or have mental disorders;

8. 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:

1. 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;

2. 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;

3. 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;

4. Uncontrollable pleural effusion, ascites, and moderate or higher amounts of pericardial effusion that require repeated drainage;

5. Known presence of cancerous meningitis or clinically active central nervous system metastasis;

6. Severe bone damage caused by tumor bone metastasis. Suffering from lung diseases that have been determined by the researcher to be unsuitable for participation in this study.

• Individuals who are known to be allergic to the investigational drug or its excipients, or allergic to humanized monoclonal antibody products.

• Individuals who have participated in and used other anti-tumor clinical trial drugs within 4 weeks prior to the first medication use.

• According to the judgment of the researchers, there are situations that seriously endanger the safety of the subjects or affect their completion of the study.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Bozhou People's Hospital	Bozhou	Anhui
China	Chuzhou First People's Hospital	Chuzhou	Anhui
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Public Health Clinical Center	Hefei	Anhui
China	Ma'anshan People's Hospital	Ma'anshan	Anhui
China	Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Suzhou Municipal Hospital	Suzhou	Zhejiang
China	Wenzhou Medical University Affiliated First Hospital	Wenzhou	Zhejiang
China	Wuhu Hospital Affiliated to East China Normal University	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-free survival	From randomization to the time of disease progression or death, whichever occurs first.	Up to 36 months after study start
Secondary	Duration of disease remission	For subjects whose best response is CR or PR , it is defined as from the date when tumor response is first recorded to the date when disease progression is first recorded or the date of death from any cause, whichever occurs first.	Up to 24 months after study start
Secondary	Disease control rate	Percentage of subjects with CR, PR, or stable disease(SD) at 6 weeks or more as determined by RECIST 1.1.	Up to 24 months after study start
Secondary	Clinical benefit rate	The percentage of subjects achieving CR, PR or SD as assessed by the investigator based on the RECIST 1.1.	Up to 24 months after study start
Secondary	Overall survival	From randomization to the time of death from any cause.	Up to 48 months after study start
Secondary	Incidence of adverse events	All adverse medical events (e.g. adverse events, serious adverse event and abnormal laboratory values) that occurred after the subject received the investigational drug.	Up to 36 months after study start
Secondary	Anti-drug antibody (ADA)	Incidence of ADA	1 hour Before infusion on Cycle 1 Day1, Cycle 2 Day1, Cycle 4 Day1, Cycle 7 Day1, Cycle 12 Day1, and 30 days after the end of the last infusion. Each cycle is 21 days
Secondary	HER2	Correlation analysis between HER2 expression level and TQB2102 treatment response	Up to 24 months after study start
Secondary	circulating tumor DNA (ctDNA)	Exploring the genetic variation and dynamic changes of ctDNA, including ctDNA clearance?	Up to 24 months after study start