Clinical trial NCT06452706: The Clinical Trial of TQB2102 for Injection Against Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: Up to 24 months after study start.
Secondary outcomes:
measure: Progression-free survival
timeFrame: Up to 36 months after study start
measure: Duration of disease remission
timeFrame: Up to 24 months after study start
measure: Disease control rate
timeFrame: Up to 24 months after study start
measure: Clinical benefit rate
timeFrame: Up to 24 months after study start
measure: Overall survival
timeFrame: Up to 48 months after study start
measure: Incidence of adverse events
timeFrame: Up to 36 months after study start
measure: Anti-drug antibody (ADA)
timeFrame: 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
measure: HER2
timeFrame: Up to 24 months after study start
measure: circulating tumor DNA (ctDNA)
timeFrame: Up to 24 months after study start
Other outcomes:
Locations:
city: Bozhou
country: China
facility: Bozhou People's Hospital
state: Anhui
city: Chuzhou
country: China
facility: Chuzhou First People's Hospital
state: Anhui
city: Hefei
country: China
facility: Anhui Provincial Public Health Clinical Center
state: Anhui
city: Ma'anshan
country: China
facility: Ma'anshan People's Hospital
state: Anhui
city: Wuhu
country: China
facility: Wuhu Hospital Affiliated to East China Normal University
state: Anhui
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: The Third People's Hospital of Zhengzhou
state: Henan
city: Zhengzhou
country: China
facility: The First People's Hospital of Zhengzhou
state: Henan
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Changde
country: China
facility: The First People's Hospital of Changde City
state: Hunan
city: Shanghai
country: China
facility: Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Ürümqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Medical University Affiliated First Hospital
state: Zhejiang
Study officials:
References: