Gynecological Tumors
Conditions
Brief summary
TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), a 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 2 study to evaluate the efficacy,and safety of TQB2102 for injection in recurrent/metastatic advanced gynecological tumors.
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
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects voluntarily participate in this study, sign informed consent and have good compliance. * The age is ≥ 18 years old (subject to the date of signing the informed consent); Female ; eastern cooperative oncology group (ECOG ) score 0-1 ; estimated survival time ≥ 3 months ; * Histologically confirmed, unresectable recurrent / metastatic advanced gynecologic tumors; * The HER2 expression status (IHC 3+, 2+, 1+ or 0) is confirmed in the tumor tissue, and the subjects with completely negative IHC 0 staining are excluded. * Previous chemotherapy with platinum-based drugs was unsuccessful. * There is at least one measurable lesion according to the RECIST 1.1 criteria; women of childbearing potential need to meet the following conditions: the serum/urine pregnancy test result is negative before the first administration; they agree to adopt highly effective contraceptive measures (with an annual failure rate of less than 1%) throughout the study period. Women of childbearing potential are defined as premenopausal women who have not had a record of tubal ligation or hysterectomy, or women who have been postmenopausal for no more than 1 year.
Exclusion criteria
* Other malignant tumors occurred within the past 5 years before treatment or currently suffered simultaneously. * Uncontrollable toxic reactions above CTCAE Grade 1 caused by any previous treatment, excluding alopecia. * Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days before the start of treatment. * Long-term unhealed wounds or fractures. * Subjects with a history of interstitial lung disease/pneumonia ( non-infectious type ) that required steroid drug intervention treatment in the past, or currently accompanied by interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening imaging and cannot be excluded. * Subjects with moderate to severe pulmonary dysfunction/disease within 3 months before the first administration. * Arterial/deep vein thrombosis events occurred within 6 months before treatment, such as cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism. * Subjects with any severe and/or uncontrolled diseases. * Patients with local recurrence suitable for surgery or radiotherapy. * Those with disease progression after receiving chemotherapy drugs of topoisomerase I inhibitors or ADC drugs with small molecule toxins as topoisomerase I inhibitors in the previous first-line treatment. * Any anti-cancer therapy or any other experimental drug treatment within 28 days or 5 half-lives before the first administration in this study. * Received treatment with Chinese patent medicines with clear anti-tumor indications in the drug instructions approved by National Medical Products Administration (NMPA) within 2 weeks before the first administration in this study. * Serosal effusion that requires repeated drainage to relieve clinical symptoms, or those who received serosal effusion drainage for treatment purposes within 2 weeks before treatment. * Patients with clinically significant tumor bleeding or perforation within 1 month before the start of the study treatment, or any bleeding event ≥ CTCAE Grade 3, or patients with bleeding or coagulation disorders who are using warfarin, aspirin, or other antiplatelet aggregation drugs. * Subjects with known central nervous system metastasis and/or carcinomatous meningitis, with diffuse dissemination. Subjects with a history of brain metastasis may be considered for inclusion if clinically stable. * Severe bone damage and spinal cord compression caused by tumor bone metastasis, including weight-bearing bone pathological fractures that occurred within 6 months or are likely to occur in the near future, poorly controlled severe bone pain, etc. * Those allergic to macromolecular drug components or allergic to any research drug, any component or excipient in the drug. * Received live attenuated vaccines within 4 weeks before treatment. * Active autoimmune diseases that required systemic treatment (such as using disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first administration. * Received systemic glucocorticoid treatment or any other form of immunosuppressive therapy or diagnosed with immunodeficiency within 2 weeks before treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Baseline up to 12 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 12 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. |
| Overall survival (OS) | Baseline up to 17 months | OS defined as the time from the first injection to death from any cause. |
| Disease control rate (DCR) | Baseline up to 12 months | DCR defined as percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD). |
| Duration of remission (DOR) | Baseline up to 12 months | DOR defined as the time when the participants first achieved complete or partial remission to disease progression. |
| 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. |
| Anti-drug antibody (ADA) | Before infusion on cycle1 day1, cycle2 day1,cycle 4 day1, cycle7 day1, cycle12 day1 (each cycle is 21 days), 30 days after the end of the last infusion | Incidence of anti-drug antibody (ADA). |
| Frequency 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. |
Countries
China
Contacts
Primary ContactJundong Li, Master
Backup ContactYang Sun, Doctor
Outcome results
None listed