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| Name | Class |
|---|---|
| Fudan University | OTHER |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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This research includes two parts: the first part of the patients with late malignant tumor monotherapy study, at the beginning of the second part in treat DLBCL and research on combination therapy in patients with advanced breast cancer.
Research purpose: to evaluate XZ120 safety, tolerability, for the treatment of malignant tumor patients pharmacokinetic characteristics and preliminary effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XZ120 monotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XZ120 injection | Drug | in Part One:XZ120 monotherapy, IV, no less than 60min, Q3W dose escalation study: 4 dose group (0.75 mg/m2, 1.5 mg/m2, 2.25 mg/m2, 3.0 mg/m2) Dose expansion study: MTD dose |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of XZ120 treatment-emergent adverse events | Adverse Events | 36 courses(approximately 2 years) |
| The maximum tolerated dose and/or the recommended phase II dose of XZ120 | Dose Finding | Course 1 (the first 3 weeks of treatment) |
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Inclusion Criteria:
male or female aged ≥18 years old;
The enrolled population was divided into the first part of monotherapy and the second part of combination therapy:
The first part of the monotherapy study was as follows:
A: single drug dose escalation is confirmed by histology and cytology and received a standard after treatment failure or intolerance to standard treatment or for other reasons can not accept standard or the lack of effective treatment of patients with late malignant tumor; B:Single-agent dose expansion: patients with histologically or cytologically confirmed advanced breast cancer who are eligible for standard anthracycline monotherapy;
The second part of the combination therapy dose expansion phase consists of the following cohorts:
Cohort 1: the pathology diagnosed patients with DLBCL treated first; Cohort 2: Histologically or cytologically confirmed advanced breast cancer patients eligible for anthracycline-based standard therapy;
Note: The patients with advanced breast cancer met any of the following criteria: â‘ Initially diagnosed as inoperable locally advanced or metastatic breast cancer; (2) did not receive chemotherapy after the eradicative resection of recurrent or metastatic breast cancer; â‘¢ Recurrent or metastatic breast cancer after receiving anthracyclines for more than 12 months;
subjects with at least one measurable and evaluable target lesion were enrolled in the dose-expansion phase;
patients with ECOG performance status score of 0-1;
dose extension stage lymphoma patients international prognostic index (IPI) score of 0 ~ 2 points;
the researchers determine subjects were expected to survive a period of 3 months or more;
heart echocardiography measured LVEF 50% or higher;
important organ function meet the following requirement (first dose not allowed within 2 weeks before blood transfusion treatment, and use the growth factors of drug) : Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L; The platelet count 75 x 109 / L or higher; Hemoglobin (Hb) ≥90g/L; Liver function: aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤2.5×ULN, total bilirubin (TBIL) ≤1.5×ULN; If there is liver metastasis, AST and ALT≤5×ULN, TBIL≤3×ULN; Renal function: serum creatinine (Cr) <1.5×ULN or creatinine clearance ≥50mL/min (Cr≥1.5×ULN); coagulation function: international standardization ratio (INR) 1.5 x ULN or less and part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
understand the procedure and content of the trial and sign the informed consent form voluntarily.
Exclusion Criteria:
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