Breast Cancer
Conditions
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.
Interventions
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Baseline up to 10 months. | ORR defined as percentage of participants achieving complete response (CR) and partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed