Phase I Study of XZ120 in Malignant Tumors

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

123 Participants
are divided into 1 treatment group
Group A: XZ120 monotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of XZ120 treatment-emergent adverse events

Adverse Events

Time frame
36 courses(approximately 2 years)
2

The maximum tolerated dose and/or the recommended phase II dose of XZ120

Dose Finding

Time frame
Course 1 (the first 3 weeks of treatment)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong New Time Pharmaceutical Co., LTD

Lead sponsor

Fudan University

Collaborator

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator

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