Solid Tumors
Conditions
Interventions
Group 1:HF158K1 1.4 g,Q3W,intravenous infusion for 90 ± 10 min.
Group 2:HF158K1 2.2 g,Q3W,intravenous infusion for 90 ± 10 min.
Group 3:HF158K1 2.9 g,Q3W,intravenous infusion for 90 ± 10 min.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study, sign written informed consent, and be able to comply with all study-related procedures; 2. Adults, male or female, =18 years old and =75 years old at the time of signing the informed consent; 3. Patients with unresectable or metastatic advanced solid tumors, confirmed by histology or cytology, who have failed or cannot tolerate previous standard treatment (disease progression, or cannot tolerate chemotherapy, targeted therapy, etc.), or who currently have no standard treatment options; Definition of HER-2 expression: The results of HER-2 immunohistochemical test were IHC 3+ 2+ 1+. The urothelial carcinoma referred to the "Chinese Expert Consensus on Clinical pathology of human epidermal growth factor receptor 2 detection in Urothelial carcinoma", and the breast cancer referred to the "Guidelines for HER2 detection in breast cancer" (HER2 ultra low also considered HER2 expression). Gastric cancer was referred to "Chinese Expert consensus on HER-2 detection in gastroscopic biopsy specimens of gastric cancer", and other solid tumors were referred to breast cancer standards. 4. Eastern Cooperative Oncology Group (ECOG) performance status score 0-1; 5. The expected survival time is not less than 6 months; 6. At least one measurable lesion according to RECIST v1.1; 7. Vital organ and bone marrow functions meet the following requirements: a) bone marrow reserve: neutrophil count >=1.5×10^9/L, lymphocyte count >=1.0×109/L, platelet count >=90×10^9/L, and hemoglobin >=8.0 g/dL (without transfusion or hematopoietic stimulating factor therapy within 14 days); b) Coagulation function: activated partial prothrombin time (APTT) prolongation =30 mL/min (Cockcroft-Gault formula); e) left ventricular ejection fraction >=50%; 8. Reproductive-age participants (including male participants) must agree not to plan to become pregnant during the trial until 6 months after the last dose and must voluntarily use an effective contraceptive method with their partner; Women of childbearing age must have a negative blood pregnancy test between the screening period and the first dose;
Exclusion criteria
Exclusion criteria: 1.Prior systemic doxorubicin therapy with cumulative dose >=350 mg/m^2 before screening (equivalent doses of other anthracyclines: 1 mg doxorubicin = 2 mg epirubicin, 2 mg pirarubicin, 2 mg daunorubicin, or 0.5 mg idarubicin); or prior anthracycline-induced severe cardiotoxicity; or treatment discontinuation due to severe adverse reactions to liposomal doxorubicin. 2.Current use of immunosuppressive agents or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 4 weeks prior to the first dose. Subjects receiving topical hormonal therapy are eligible. 3.Receipt of prior systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy 14 days, and no clinical symptoms.) 5.Failure to recover from all adverse events of prior therapy to =3 cardiovascular or cerebrovascular events within 6 months before the first dose; d) Uncontrolled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg). Patients with a history of hypertension are eligible if blood pressure is controlled below these limits with antihypertensive medication. 7.Active infection or unexplained fever >38.5 °C within 1 week before the first dose (subjects with tumor-related fever, as judged by the investigator, may be enrolled). 8.HIV infection, active HBV infection (HBV DNA above upper limit of normal), or active HCV infection (HCV RNA above upper limit of normal). 9.Pregnant or lactating female subjects. 10.Any other severe systemic disease or other conditions that, in the investigator’s opinion, render the subject ineligible for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;The Recommended Phase 2 Dose (RP2D);Tolerability;Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic Characteristics;Preliminary anti-tumor activity;Immunogenicity; | — |
Countries
China
Contacts
Public ContactKai Yao
Sun Yat-sen University Cancer Center
Outcome results
None listed