Phase I Study of XZ120 in Malignant Tumors
ConditionAdvanced Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorShandong New Time Pharmaceutical Co., LTD
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
Qualifiers
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
Treatments tested in this trial
- XZ120 injection
Treatment groups
123 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Shandong New Time Pharmaceutical Co., LTD
Lead sponsor
Fudan University
Collaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Collaborator
Source ClinicalTrials.gov