A Study of XZB-0004 in Patients With Solid Tumors

PHASE1RecruitingINTERVENTIONAL
Enrollment

128

Participants

Timeline

Start Date

March 24, 2023

Primary Completion Date

June 30, 2025

Study Completion Date

February 28, 2027

Conditions
Advanced Solid TumorNSCLC
Interventions
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.

Trial Locations (1)

200433

RECRUITING

Shanghai Pulmonary Hospital, Shanghai

All Listed Sponsors
lead

Xuanzhu Biopharmaceutical Co., Ltd.

INDUSTRY