NCT05772455

A Study of XZB-0004 in Patients With Solid Tumors

A Phase I, Open-label, Dose-escalation Study of the Safety, Pharmacokinetics and Efficacy of the XZB-0004 in Patients With Solid Tumours

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Xuanzhu Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

XZB-0004 is a novel and potent small molecule inhibitor of receptor tyrosine kinase AXL. This is an open-label, multicentre phase I study of XZB-0004 in patients with solid tumors. Part 1 is a dose-escalation study to evaluate the safety, pharmacokinetic (PK), and pharmacodynamic profile of XZB-0004, and then to identify a safe and pharmacologically active dose for evaluation in subsequent cohorts or clinical studies. Part 2 is a study to evaluate the efficacy and safety of XZB-0004 combined with Penpulimab in patients with NSCLC or advanced solid tumors.

Conditions

• Advanced Solid Tumor
• NSCLC

Interventions

Type	Name	Description
DRUG	XZB-0004	Part 1a: 100mg BID, 150mg BID, and 200mg BID of XZB-0004 are planned to be evaluated, and the possibility of exploring higher or lower doses is not ruled out. Continuous administration of XZB-0004 for 21 days is a treatment cycle. Part 1b: XZB-0004 in combination with Penpulimab in subjects with advanced NSCLC or solid tumors, starting at a dose level down from the RP2D of XZB-0004 monotherapy- cohort 1: Advanced or metastatic NSCLC with advanced disease progression after treatment with PD-1 or PD-L1 inhibitors; cohort 2: Advanced or metastatic NSCLC with advanced disease progression after platinum-containing chemotherapy without prior use of any immunocheckpoint inhibitors; cohort3: Advanced or metastatic solid tumors that cannot be radically cured by surgery or local therapy, including but not limited to urothelial carcinoma, melanoma, etc. Subjects had disease progression since last antitumor therapy, no availability or intolerance or refusal of standard therapy.

Timeline

• Start date: 2023-03-24
• Primary completion: 2025-06-01
• Completion: 2027-02-01
• First posted: 2023-03-16
• Last updated: 2024-10-28

Locations

1 site across 1 country: China