NCT06206915

Phase I Study of XZ120 in Malignant Tumors

To Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of XZ120 in Patients With Malignant Tumors in a Phase Ⅰ Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Shandong New Time Pharmaceutical Co., LTD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Advanced Malignancies

Interventions

Type	Name	Description
DRUG	XZ120 injection	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

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-02-01
• Completion: 2027-02-01
• First posted: 2024-01-16
• Last updated: 2024-01-16