Advanced solid tumor
Conditions
Interventions
experimental group:DXC1002
Sponsors
Fudan University Shanghai Cancer Cen
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily signed the informed consent form and followed the protocol requirements. 2. Gender is not limited, = 18 years and = 75 years old. 3. The expected survival time = 3 months. 4. Histopathological or cytologically confirmed metastatic solid cancers or locally advanced solid tumors, including TNBC, hormone receptor-positive breast cancer, NSCLC, small cell lung cancer, gastric cancer, urothelial carcinoma and ovarian cancer, et al. 5. Patients must be refractory or intolerant to all standard approved treatments with a variety of metastatic solid cancers or locally advanced solid tumors. 6. The toxicities of previous anti-tumor treatment have been restored to grade = 1 defined by NCI-CTCAE v5.0 (except for alopecia and vitiligo). or grade = 2 judged by investigators (e.g. peripheral neuropathy = Grade 2). 7. = 1 measurable lesion according to RECIST 1.1. 8. Eastern Cooperative Oncology Group (ECOG) score 0 or 1. 9. The level of organ/system functions must meet the following requirements: • Blood Routine: neutrophil count (ANC) = 1.5×109/L; Platelet count = 90×109/L;Hemoglobin (HGB) = 90 g/L. • Coagulation function: international standardized ratio (INR) = 1.5, prothrombin time (PT) or activated partial thrombin time (APTT) = 1.5×ULN. • Liver: total bilirubin = 1.5×ULN, (total bilirubin = 3×ULN in patients with Gilbert's syndrome); AST and ALT =2.5×ULN. AST and ALT = 5×ULN in patients with liver metastasis. • Kidney: creatinine = 1.5×ULN; creatinine clearance (Ccr) = 60mL/min, uroprotein=1+ in URT; uroprotein = 1g/24h in patients with uroprotein = 2+. • Heart: patients without severe abnormality in heart function; left ventricular ejection fraction (LVEF) = 50%. 10. Patients and partners with child-bearing potential should agree to use effective contraceptive methods (e.g. oral contraceptives, intrauterine devices, abstinence or barrier contraception combined with spermicide) during drug administration period and within 6 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Patients have received chemotherapy, radiotherapy, immunotherapy, biotherapy or investigational drug therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose; endocrine therapy or small molecular targeted therapy within 2 weeks prior to the first dose. 2. Major surgery within 4 weeks prior to the first dose. 3. Treatment with > 10 mg of prednisone or equivalent doses of systemic corticosteroids, anti-inflammatory drug or immunosuppressive therapy within 2 weeks before the first dose. 4. Received live attenuated vaccine within 4 weeks before the first dose or planning to receive live attenuated vaccine during investigational drug treatment. 5. History of other primary malignant tumors (except for malignant tumors that have been cured, e,g, basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, thyroid cancer and ductal carcinoma in situ; cancer patients with disease-free survival > 5 years). 6. CNS tumor or brain metastases (except for the brain metastases patients without symptoms or symptoms stable, in no need of corticosteroids or other treatments = 28 days, imaging during screening period indicating diseases stable). 7. High blood pressure controlled poorly with drugs (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg). 8. Uncontrollable or severe heart diseases, e, g, Grade III or IV heart failure (New York Heart Association Functional Grading System); unstable angina pectoris controlled poorly with drugs; history of myocardial infarction within 6 months before screening, sever arrhythmias treated with drugs(except for atrial fibrillation and paroxysmal supraventricular tachycardia). 9. Oxygen therapy needed during activities of daily living. 10. QTcF interval = 470 ms (QT interval should be corrected by Fridericia formula [QTcF]). 11. Active hepatitis B (hepatitis B antigen positive and HBV-DNA > 500 IU /mL or 2000 copies /mL); Active hepatitis C infection (hepatitis C antibody positive and hepatitis C RNA > LLOD). 12. HIV positive or with the history of HIV; syphilis antibodies positive; active tuberculosis (imaging within 3 months prior to first dosing indicating active tuberculosis infection). 13. Corticosteroids needed in patients with Interstitial lung Disease or non-infectious pneumonia; lung function damaged severely by lung diseases. 14. Acitve infection in patients who needed treatments or fever > 38.5? (except for tumor fever) within 2 weeks prior to the first dose. 15. Severe thrombosis in patients who needed treatments (except for stable deep venous thrombosis) within 12 months before the first dose. 16. Female patients in gestational period or lactation period. 17. Treatments needed in patients with pericardial, pleural or peritoneal effusion with symptoms and syndromes. 18. Other cases that the investigator believes not appropriate for this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MTD;DLT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic (PK) characteristics;immunogenicity;clinical effect; | — |
Countries
China
Contacts
Public ContactJian Zhang
Fudan University Shanghai Cancer Center
Outcome results
None listed