a study of tqb2102 for injection in patients with recurrent/metastatic breast cancer

Conditions: Breast Cancer

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.


Eligibility criteria:
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.