Rare malignant tumors in advanced stages
Conditions
Interventions
Experimental group:Disitamab vedotin for injection
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in the study and sign an informed consent form; 2. Male or female, age =18 years old; 3. Expected survival period =12 weeks; 4. Locally progressive or metastatic rare malignant tumors with histopathological diagnosis that cannot be completely resected by surgery; 5. The disease has progressed after receiving at least first-line standard systemic treatment in the past. If the patient has disease progression within 3 months after receiving neoadjuvant or adjuvant chemotherapy treatment, he or she can be enrolled in this clinical study; 6. Have measurable lesions as specified by RECIST v1.1 standards; 7. The subject can provide primary or metastatic tumor specimens that can be used for HER2 testing; and the HER2 immunohistochemistry result is 2+ or 3+; 8. ECOG physical status score 0-2 points; 9.Adequate heart, bone marrow, liver, and kidney functions (based on the normal values of the research center): (1) Left ventricular ejection fraction =50%; (2) Hemoglobin =10g/dL; (3) Absolute neutrophil count (ANC) =1.5×10^9/L; (4) Platelets =100 ×10^9/L (5) For patients without liver metastasis, the serum total bilirubin is =1.5 times the upper limit of normal (ULN); for those with liver metastasis, the serum total bilirubin is =3× ULN; (6) ALT and AST = 2.5 × ULN when there is no liver metastasis, and ALT and AST = 5 × ULN when there is liver metastasis; (7) Serum creatinine =1.5×ULN; 10. For female subjects: they should be surgically sterilized, postmenopausal, or agree to use at least one medically approved contraceptive method (such as intrauterine device) during the study treatment period and within 4 months after the end of the study treatment period. [IUD], birth control pills or condoms), must have a negative serum or urine pregnancy test within 7 days prior to study enrollment, and must be non-lactating. Male subjects should agree to use at least one medically approved contraceptive method (such as condoms, abstinence, etc.) during the study treatment period and within 4 months after the end of the study treatment period; 11. Willing and able to comply with trial and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. People who are known to be allergic to recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate drugs and related components; 2. Have received anti-tumor treatment (including chemotherapy, radiotherapy, immunotherapy, etc.) or participated in other clinical research treatments within 3 weeks before the start of study treatment, or the toxicity related to previous anti-tumor treatment has not recovered to grade 0-1 (except grade 2 alopecia) ); 3. Have previously received drug treatment with recombinant humanized anti-HER2 monoclonal antibody-MMAE conjugate; 4. Had major surgery within 4 weeks before the start of study administration and did not fully recover; 5. Other serious, uncontrollable concomitant diseases that may affect protocol compliance or interfere with interpretation of results, including active infections, uncontrolled diabetes, cardiovascular and cerebrovascular diseases (Class III or IV heart disease as defined by the New York Heart Association) Failure, second degree or higher heart block, acute myocardial infarction, unstable arrhythmia or unstable angina within the past 6 months, cerebral infarction within 6 months, etc. (excluding lacunar infarction) or pulmonary disease (history of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchospasm), deep vein thrombosis, or pulmonary embolism; 6. Suffering from other malignant tumors within 3 years before the start of study administration, but excluding malignant tumors that have been obviously cured, or cancers that can be cured, such as basal skin cancer or squamous cell skin cancer, localized low-risk prostate cancer, cervical cancer Carcinoma in situ or carcinoma in situ of the breast; Note: Patients with localized low-risk prostate cancer (defined as stage = T2a, Gleason score = 6, and PSA < 10 ng/mL (if measured) at the time of prostate cancer diagnosis) have undergone radical treatment Those who have undergone sexual therapy and have no biochemical recurrence of prostate-specific antigen (PSA) can participate in this study); 7. Suffering from central nervous system (CNS) metastasis and/or cancerous meningitis. Subjects who have previously received treatment for brain metastases may be considered for participation in this study, provided that their condition has been stable for at least 3 months, no disease progression has been confirmed by imaging examination within 4 weeks before the first dose of the study, and all neurological symptoms have recovered As of baseline, there was no evidence of new or expanding brain metastases, and radiation, surgery, or steroid therapy was discontinued at least 28 days before the first dose of study treatment. This exception does not include cancerous meningitis, which should be excluded regardless of clinical stability; 8. Pregnant or lactating women; 9. HIV test result is positive; 10. Patients with active hepatitis B or hepatitis C 1) Patients who are HBsAg positive are also tested positive for HBV DNA copy number; 2) Patients with positive HCV antibody test results can be selected for this study only if the HCV RNA PCR test result is negative. 11. There is an active or progressive infection that requires systemic treatment, such as active tuberculosis; 12. Suffer from any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory test. According to the judgment of the researcher, there is reason to suspect that the patient has a certain disease or state that i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate;Progression Free Survival;Adverse Reactions;OS; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed