A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQB2102 for injection Dose: 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. |
Drug: TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate (ORR) [Baseline up to 10 months.]
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).
Secondary Outcome Measures
- Progression-Free Survival (PFS) [Baseline up to 14 months.]
PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.
- Duration of Remission (DOR) [Baseline up to 14 months.]
DOR defined as the time when the participants first achieved complete or partial remission to disease progression.
- Disease Control Rate (DCR) [Baseline up to 10 months.]
Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).
- Clinical Benefit Rate (CBR) [Baseline up to 14 months.]
Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for ≥ 24 weeks.
- Overall Survival (OS) [Baseline up to 20 months.]
OS defined as the time from the first injection to death from any cause.
- Incidence of adverse event (AE) [From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.]
The occurrence of all adverse medical events after the first injection.
- Severity of adverse event (AE) [From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.]
The severity of all adverse medical events after the first injection.
- Concentration of TQB2102 [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.]
Serum concentration of TQB2102
- Concentration of total antibody [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.]
Total antibody concentration in serum
- Small molecule toxin [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.]
Small molecule toxin in plasma
- Anti-drug antibody (ADA) [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.]
Incidence of anti-drug antibody (ADA)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects voluntarily participate in this study and sign informed consent;
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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;
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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;
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Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;
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At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
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The main organs function are normally;
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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.
Exclusion Criteria:
- Concomitant disease and medical history:
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Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
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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);
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Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
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Long-term unhealed wounds or fractures;
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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;
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Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
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Patients with any severe and/or uncontrolled disease;
- Tumor related symptoms and treatment:
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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;
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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;
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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;
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Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
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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;
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Patients with severe bone injury due to tumor bone metastasis;
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Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;
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Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anhui Pronvincial Cancer Hospital | Hefei | Anhui | China | 230000 |
| 2 | Lu'an People's Hospital | Lu'an | Anhui | China | 237008 |
| 3 | Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing | China | 100021 |
| 4 | Chongqing University Cancer Hospital | Chongqing | Chongqing | China | 400030 |
| 5 | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | China | 510060 |
| 6 | Jiangmen Central Hospital | Jiangmen | Guangdong | China | 529000 |
| 7 | Guangxi Medical University Cancer Hospital | Nanning | Guangxi | China | 530021 |
| 8 | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China | 150081 |
| 9 | Hunan Cancer Hospital | Changsha | Hunan | China | 410031 |
| 10 | Ganzhou People's Hospital | Ganzhou | Jiangxi | China | 341000 |
| 11 | Jilin Cancer Hospital | Changchun | Jilin | China | 130012 |
| 12 | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning | China | 110000 |
| 13 | The First Hospital of China Medical University | Shenyang | Liaoning | China | 110001 |
| 14 | Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | China | 250117 |
| 15 | Linyi Cancer Hospital | Linyi | Shandong | China | 276034 |
| 16 | The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine | Xi'an | Shannxi | China | 710089 |
| 17 | Shanxi Cancer Hospital | Taiyuan | Shanxi | China | 030000 |
| 18 | Suining Central Hospital | Suining | Sichuan | China | 629000 |
| 19 | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin | China | 300202 |
| 20 | Affiliated Tumor Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | China | 830054 |
| 21 | Zhejiang Cancer Hospital | Hangzhou | Zhejiang | China | 310022 |
Sponsors and Collaborators
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TQB2102-Ib-01