Breast Cancer Clinical Trial
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Concomitant disease and medical history: 1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug; 2. 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); 3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment; 4. Long-term unhealed wounds or fractures; 5. 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; 6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication; 7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders; 8. Patients with any severe and/or uncontrolled disease; - Tumor related symptoms and treatment: 1. 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; 2. 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; 3. 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; 4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage; 5. 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; 6. 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. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing |
China | Jilin Cancer Hospital | Changchun | Jilin |
China | Hunan Cancer Hospital | Changsha | Hunan |
China | Chongqing University Cancer Hospital | Chongqing | Chongqing |
China | Ganzhou People's Hospital | Ganzhou | Jiangxi |
China | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong |
China | Zhejiang Cancer Hospital | Hangzhou | Zhejiang |
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | Anhui Pronvincial Cancer Hospital | Hefei | Anhui |
China | Jiangmen Central Hospital | Jiangmen | Guangdong |
China | Cancer Hospital Affiliated to Shandong First Medical University | Jinan | Shandong |
China | Linyi Cancer Hospital | Linyi | Shandong |
China | Lu'an People's Hospital | Lu'an | Anhui |
China | Guangxi Medical University Cancer Hospital | Nanning | Guangxi |
China | Liaoning Cancer Hospital & Institute | Shenyang | Liaoning |
China | The First Hospital of China Medical University | Shenyang | Liaoning |
China | Suining Central Hospital | Suining | Sichuan |
China | Shanxi Cancer Hospital | Taiyuan | Shanxi |
China | Tianjin Medical University Cancer Institute & Hospital | Tianjin | Tianjin |
China | The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine | Xi'an | Shannxi |
Lead Sponsor | Collaborator |
---|---|
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Response Rate (ORR) | ORR defined as percentage of participants achieving complete response (CR) and partial response (PR). | Baseline up to 10 months. | |
Secondary | 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. | Baseline up to 14 months. | |
Secondary | Duration of Remission (DOR) | DOR defined as the time when the participants first achieved complete or partial remission to disease progression. | Baseline up to 14 months. | |
Secondary | Disease Control Rate (DCR) | Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD). | Baseline up to 10 months. | |
Secondary | Clinical Benefit Rate (CBR) | Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for = 24 weeks. | Baseline up to 14 months. | |
Secondary | Overall Survival (OS) | OS defined as the time from the first injection to death from any cause. | Baseline up to 20 months. | |
Secondary | Incidence of adverse event (AE) | The occurrence of all adverse medical events after the first injection. | From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first. | |
Secondary | Severity of adverse event (AE) | The severity of all adverse medical events after the first injection. | From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first. | |
Secondary | Concentration of TQB2102 | Serum 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. | |
Secondary | Concentration of total antibody | Total antibody concentration in serum | 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. | |
Secondary | Small molecule toxin | Small molecule toxin in plasma | 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. | |
Secondary | Anti-drug antibody (ADA) | Incidence of 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. |
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