Breast and urothelial cancer
Conditions
Interventions
Experimental Group:Breast cancer: HuA21+trastuzumab (Herceptin)+pyrotinib+capecitabine and HuA21+ricotumumab.
Urothelial carcinoma: HuA21+trastuzumab (Herceptin)+albumin-bound paclitaxel and HuA21 In
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in clinical research and sign an Informed Consent Form (ICF). 2. Aged =18 years, gender not limited. 3. Histologically or cytologically confirmed inoperable/metastatic advanced solid tumors, currently the study selects breast cancer and urothelial carcinoma; 2. Age >=18 years old, gender not limited; 3. Histologically or cytologically confirmed inoperable/metastatic advanced solid tumors, currently research focuses on breast cancer and urothelial cancer; and all have radiographic evidence of tumor disease progression during or after the most recent treatment confirmed by the investigator. 4. Patients with advanced breast cancer with high HER2 expression: Tumor tissues were detected by immunohistochemistry (IHC) with a score of 3+ or higher, or IHC2+ and FISH positive; Cohort 1: Previously treated with THP in advanced or metastatic phase; Cohort 2: Previously treated in advanced or metastatic stage with THPyo and an ADC (preferably trastuzumab). 5. HER2-overexpressing advanced urothelial carcinoma: tumor tissue with immunohistochemistry (IHC) test score of 2+ and above; previously treated in the advanced or metastatic stage with a gemcitabine-containing systemic regimen, with or without immune checkpoint inhibitor; Cohort 3: no prior ADC treatment; Cohort 4: Treated with ADC. 6. Have at least 1 measurable lesion as per RECIST V 1.1 criteria. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0–1 point; 8. Expected survival time at screening>=12 weeks. 9. Patients had adequate organ and bone marrow function as defined by the following laboratory criteria (institutional normal values at the clinical trial center); 10. Females of childbearing potential were not pregnant or nursing and had a negative blood pregnancy test within 7 days prior to the first dose of study medication. Male or female patients of childbearing potential must have agreed to use at least one medically accepted contraceptive method during the study and for 6 months after the last study dose. Female subjects should avoid donating oocytes or breastfeeding during the study and for 6 months following the last dose of study drug. Male subjects should avoid donating sperm during the study and for 6 months following the last dose of study drug.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of known immune deficiency, including HIV positive test results, or suffering from other acquired or congenital immune deficiency diseases, or with a history of organ transplantation. 2. Treatment with an attenuated live vaccine within 28 days prior to enrollment. 3. Patients with active hepatitis B (HBsAg positive and HBV DNA>=2500 copies/mL or 500 IU/mL or not within the normal range of this center), hepatitis C antibody (HCV-Ab) positive and hepatitis C virus ribonucleic acid (HCV-RNA) positive, co-infection of hepatitis B and hepatitis C (i.e., HBsAg positive or HBcAb positive, and HCV antibody positive), and who have not received antiviral drug treatment. 4. Severe allergic reaction to the study drug or a related drug or an excipient of either. 5. There is a history of drug abuse, psychiatric or abnormal diseases, or any other medical conditions that the investigator considers may increase the risk to the subject's safety or interfere with the subject's participation in the clinical study or clinical study evaluation. 6. Active brain metastases requiring dehydration and hormone therapy and/or carcinomatous meningitis. 7. Individuals with a history of acute myocardial infarction, drug-treated unstable angina, stroke or transient ischemic attack, poorly controlled arrhythmias within the 6 months prior to enrollment, congestive heart failure with a New York Heart Association (NYHA) classification greater than or equal to 2, left ventricular ejection fraction (LVEF) less than 50%, and poorly controlled hypertension with multiple readings of systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg after treatment with three or more antihypertensive drugs. 8. Participants who are currently participating in clinical research of other unmarketed drugs or have participated in clinical research of other unmarketed drugs within 4 weeks prior to enrollment and have received trial drug administration; those who have undergone major surgery within 4 weeks prior to enrollment or are expected to require major surgery during the study treatment period. 9. Unresolved toxicity from prior anti-neoplastic therapy, defined as toxicity (except for alopecia) has not returned to <=grade 1 (NCI-CTCAE v6.0) or baseline level. Subjects with chronic grade 2 toxicity (e.g., grade 2 neuropathy) according to the Investigator’s judgement may be eligible for this study. 10. Individuals who have suffered from other malignancies within the past 5 years (except for cured skin basal cell carcinoma, cervical in situ carcinoma, papillary thyroid carcinoma, in situ breast cancer, in situ lung cancer, and minimally invasive lung cancer). 11. Uncontrolled infections requiring intravenous antibiotics, antiviral drugs, or antifungal drugs, uncontrolled and/or poorly controlled systemic diseases, as judged by the investigator: These include diabetes mellitus poorly controlled by medical treatment, autoimmune diseases, symptomatic pleural, peritoneal or pericardial effusion requiring drainage or diuretic treatment, or uncontrolled with appropriate interventions. 12. Patients who were not suitable to participate in the study for other reasons according to the investigator's judgment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of AEs and grade 3-4 AEs.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate ;Progression-free survival ;Duration of response; | — |
Countries
China
Contacts
Public ContactDu Yingying
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed