About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male or female aged ≥18 years old;
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;
Disqualifiers
always use too much Doxorubicin (or pirarubicin) > total cumulative dose of 360 mg/m2, or epirubicin total cumulative quantity > 600 mg/m2;
patients received antineoplastic therapy 4 weeks before the first dose or within 5 half-lives of the drug, whichever was less; Patients who received a modern traditional Chinese medicine preparation with anti-tumor effect approved by NMPA within 2 weeks before the first medication;
Prednisone acetate tablets at a maximum dose of >100mg or equivalent cortisol for more than 5 days for the purpose of controlling lymphoma symptoms in patients with lymphoma; For other purposes, use of prednisone acetate tablets at a dose of >30mg per day or a cortisol equivalent for more than 10 days (for patients receiving ≤30mg per day of prednisone acetate tablets or a cortisol equivalent, there was a written record of stable use of the dose for at least 4 weeks before randomization);
patients with high-grade B-cell lymphoma;
Trial design
Single group
Treatments tested in this trial
XZ120 injection
Drugin 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
Treatment groups
Trial outcomes
Primary outcomes
The incidence of XZ120 treatment-emergent adverse events
Adverse Events
The maximum tolerated dose and/or the recommended phase II dose of XZ120
Dose Finding
Locations
Sponsors and contacts
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Shandong New Time Pharmaceutical Co., LTD
Lead sponsor
Fudan University
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
This trial is not recruiting at the moment. You can still explore other options: