AzTrials
AzTrials

Breast CancerPhase 2NCT06452706

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

A Phase 2 study testing TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 16 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
TQB2102 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
16 sitesChina
Study dates
14 Nov 2024to Jun 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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;
  • 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.

Trial locations and contacts

16 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kunwei Shen, Doctor contact

13916612760

kwshen@medmail.com.cn

16 sites in 1 country

China16 sites, 16 recruiting

  • Bozhou People's Hospital

    Bozhou, Anhui, 236804

    Xiangde Jiang, Doctor, 13966536556, 13966536556@163.com

    Not yet recruiting

  • The First People's Hospital of Changde City

    Changde, Hunan, 415003

    Tao Wu, Doctor, 15873644000, 20689452@qq.com

    Not yet recruiting

  • Chuzhou First People's Hospital

    Chuzhou, Anhui, 239001

    Dongshan You, Doctor, 13955006413, 19066904@qq.com

    Not yet recruiting

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014

    Kewang Sun, Doctor, 15356182389, sunkewangwk@hotmail.com

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

    Qingyuan Zhang, 13313612989, sy86298276@163.com

    Not yet recruiting

  • Anhui Provincial Public Health Clinical Center

    Hefei, Anhui, 230031

    Yunhong Xia, Doctor, 15212782466, yhxia12@sina.com

    Not yet recruiting

  • Ma'anshan People's Hospital

    Ma’anshan, Anhui, 243000

    Fangbo Cui, Doctor, 18056891015, njucuifangbo@126.com

    Not yet recruiting

  • Ruijin Hospital ,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

    Kunwei Shen, Doctor, 13916612760, kwshen@medmail.com.cn

    Not yet recruiting

  • Suzhou Municipal Hospital

    Suzhou, Zhejiang, 234099

    Xiyong Wang, Doctor, 19805571600, xy9026@qq.com

    Not yet recruiting

  • Cancer Hospital Affiliated to Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

    Bing Zhao, Doctor, 13899908184, 819502412@qq.com

    Not yet recruiting

  • Wenzhou Medical University Affiliated First Hospital

    Wenzhou, Zhejiang, 325015

    Ouchen Wang, Doctor, 13957706099, woc099@163.com

    Not yet recruiting

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430000

    Haijun Yu, Doctor, 13971665181, doctoryhj@126.com

    Not yet recruiting

  • Wuhu Hospital Affiliated to East China Normal University

    Wuhu, Anhui, 241399

    Kewu Wang, Doctor, 15375680003, 402624423@qq.com

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

    Jin Yang, Doctor, 18991232383, yj_clinicalstudy@163.com

    Not yet recruiting

  • The Third People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450000

    Lige Yao, Doctor, 13693718212, 577663634@qq.com

    Not yet recruiting

  • The First People's Hospital of Zhengzhou

    Zhengzhou, Henan, 450003

    Dedong Wu, Doctor, 18903856148, wdd789@126.com

    Recruiting

Other trials in China

About this study

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

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

Conditions
Breast Cancer
Being tested
TQB2102 for injection
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2102 for injectionDrug

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

Study groups in NCT06452706
Study groupRoleWhat they receive
TQB2102 for injectionExperimental7.5mg/kg TQB2102, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
Receives: Drug: TQB2102 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 24 months after study start.

Secondary outcomes (9)

  1. Progression-free survival

    From randomization to the time of disease progression or death, whichever occurs first.

    Measured: Up to 36 months after study start

  2. 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.

    Measured: Up to 24 months after study start

  3. Disease control rate

    Percentage of subjects with CR, PR, or stable disease(SD) at 6 weeks or more as determined by RECIST 1.1.

    Measured: Up to 24 months after study start

  4. Clinical benefit rate

    The percentage of subjects achieving CR, PR or SD as assessed by the investigator based on the RECIST 1.1.

    Measured: Up to 24 months after study start

  5. Overall survival

    From randomization to the time of death from any cause.

    Measured: Up to 48 months after study start

  6. 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.

    Measured: Up to 36 months after study start

  7. Anti-drug antibody (ADA)

    Incidence of ADA

    Measured: 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

  8. HER2

    Correlation analysis between HER2 expression level and TQB2102 treatment response

    Measured: Up to 24 months after study start

  9. circulating tumor DNA (ctDNA)

    Exploring the genetic variation and dynamic changes of ctDNA, including ctDNA clearance。

    Measured: Up to 24 months after study start

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2024
  2. Study start14 Nov 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06452706
Sponsor's protocol ID
TQB2102-II-02
Status last verified
Apr 2024
First submitted
6 Jun 2024
Last updated
19 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 16 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kunwei Shen, Doctor (13916612760, kwshen@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: Up to 24 months after study start.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06452706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in