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Breast CancerPhase 1NCT06115902

A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer

A Phase 1 study testing TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 20 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… 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
153 participants
Where
20 sitesChina
Study dates
17 Nov 2023to 1 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • Concomitant disease and medical history:
  • Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
  • 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);
  • Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
  • Long-term unhealed wounds or fractures;
  • 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;
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  • Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
  • Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
  • Patients with any severe and/or uncontrolled disease;
  • Tumor related symptoms and treatment:
  • 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;
  • 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;
  • 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;
  • Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
  • 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;
  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • Hunan Cancer Hospital

    Changsha, Hunan, 410031

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Ganzhou People's Hospital

    Ganzhou, Jiangxi, 341000

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Anhui Pronvincial Cancer Hospital

    Hefei, Anhui, 230000

  • Jiangmen Central Hospital

    Jiangmen, Guangdong, 529000

  • Cancer Hospital Affiliated to Shandong First Medical University

    Jinan, Shandong, 250117

  • Linyi Cancer Hospital

    Linyi, Shandong, 276034

  • Lu'an People's Hospital

    Lu'an, Anhui, 237008

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi, 530021

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110000

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Suining Central Hospital

    Suining, Sichuan, 629000

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202

  • The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

    Xi'an, Shannxi, 710089

Other trials in China

About this study

Official title: 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.

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 NCT06115902
Study groupRoleWhat they receive
TQB2102 for injectionExperimentalDose: 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.
Receives: Drug: TQB2102 for injection

What is being measured

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

  1. Overall Response Rate (ORR)

    ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).

    Measured: Baseline up to 10 months.

Secondary outcomes (11)

  1. 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.

    Measured: Baseline up to 14 months.

  2. Duration of Remission (DOR)

    DOR defined as the time when the participants first achieved complete or partial remission to disease progression.

    Measured: Baseline up to 14 months.

  3. Disease Control Rate (DCR)

    Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).

    Measured: Baseline up to 10 months.

  4. Clinical Benefit Rate (CBR)

    Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for ≥ 24 weeks.

    Measured: Baseline up to 14 months.

  5. Overall Survival (OS)

    OS defined as the time from the first injection to death from any cause.

    Measured: Baseline up to 20 months.

  6. Incidence of adverse event (AE)

    The occurrence of all adverse medical events after the first injection.

    Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.

  7. Severity of adverse event (AE)

    The severity of all adverse medical events after the first injection.

    Measured: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.

  8. Concentration of TQB2102

    Serum concentration of TQB2102

    Measured: 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.

  9. Concentration of total antibody

    Total antibody concentration in serum

    Measured: 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.

  10. Small molecule toxin

    Small molecule toxin in plasma

    Measured: 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.

  11. Anti-drug antibody (ADA)

    Incidence of anti-drug antibody (ADA)

    Measured: 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.

Timeline

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

  1. First posted3 Nov 2023
  2. Study start17 Nov 2023
  3. Primary completion1 Feb 2025
  4. Study completion1 Feb 2025

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06115902
Sponsor's protocol ID
TQB2102-Ib-01
Status last verified
Jul 2026
First submitted
30 Oct 2023
Last updated
8 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TQB2102 for injection in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 20 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 7 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: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Baseline up to 10 months.). 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 NCT06115902.

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 8 Jul 2026.

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