The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ZL-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
ZL-1218 dose escalation
Combination treatment with ZL-1218
Zai Lab Site 2005
Irvine, California, United States
Zai Lab Site 2007
Detroit, Michigan, United States
Zai Lab Site 2001
Hackensack, New Jersey, United States
Incidence of Dose Limiting Toxicities
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
Time frame: Approximately 24 months
Incidence of Treatment Emergent Adverse Events
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Time frame: Approximately 24 months
Incidence of Serious adverse events
Number of subjects with Serious Adverse Events through dose escalation and expansion.
Time frame: Approximately 24 months
Clinically Significant changes in safety assessments
Changes in safety assessment parameters (e.g., vital signs, electrocardiograms \[ECGs\], and clinical laboratory results) through dose escalation and expansion.
Time frame: Approximately 24 months
ORR per RECIST 1.1
Objective Response Rate (ORR) per RECIST 1.1 through dose expansion only.
Time frame: up to 24 months
ORR per iRECIST
Objective Response Rate per iRECIST through dose expansion only.
Time frame: up to 24 months
ORR per RECIST 1.1
Objective Response Rate (ORR) per RECIST 1.1 through dose escalation only.
Time frame: up to 24 months
ORR per iRECIST
Objective Response Rate (ORR) per iRECIST through dose escalation only.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zai Lab Site 2002
New York, New York, United States
Zai Lab Site 2003
Spokane, Washington, United States
Zai Lab Site 1002
Hangzhou, China
Zai Lab Site 1001
Shanghai, China
Zai Lab Site 8005
Barcelona, Barcelona, Spain
Zai Lab Site 8001
Barcelona, Barcelona, Spain
Zai Lab Site 8007
Madrid, Madrid, Spain
...and 5 more locations
Time frame: up to 24 months
Duration of Response per RECIST 1.1
Duration of Response per RECIST 1.1 through dose escalation and expansion.
Time frame: up to 24 months
Duration of Response per iRECIST
Duration of Response per iRECIST through dose escalation and expansion.
Time frame: up to 24 months
PFS per RECIST 1.1
Progression-Free Survival (PFS) per RECIST 1.1 through dose escalation and expansion.
Time frame: up to 24 months
PFS per iRECIST
Progression-Free Survival (PFS) per iRECIST through dose escalation and expansion.
Time frame: up to 24 months
DCR per RECIST 1.1
Disease Control Rate (DCR) per RECIST 1.1 through dose escalation and expansion.
Time frame: up to 24 months
DCR per iRECIST
Disease Control Rate (DCR) per iRECIST through dose escalation and expansion.
Time frame: up to 24 months
Overall Survival
Overall Survival (OS) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): AUC
Area under curve (AUC) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): Cmax
Maximum serum concentration (CMax) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): Tmax
Time to reach Cmax (Tmax) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): Ctrough
Ctrough through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): Vss
Volume of distribution as steady state (Vss) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): CL
Clearance (CL) through dose escalation and expansion.
Time frame: up to 24 months
Pharmacokinetics (PK): t1/2
Half-life (t1/2) through dose escalation and expansion.
Time frame: up to 24 months
Immunogenicity
Incidence of anti-drug antibodies (ADAs) through dose escalation and expansion.
Time frame: up to 24 months
Immunogenicity
Quantity of anti-drug antibodies (ADAs) through dose escalation and expansion.
Time frame: up to 24 months