The purpose of this study is to evaluate the safety and tolerability of investigational study drug ZL-6201 for treating sarcoma and solid tumors cancer.
An Open-label, Phase 1a/b, Multicenter Study of ZL-6201 to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Participants with Sarcoma and Selected Solid Tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
ZL-6201 as a single-agent
Zai Lab Site 02003
Los Angeles, California, United States
RECRUITINGZai Lab Site 02026
Sarasota, Florida, United States
RECRUITINGZai Lab Site 02005
St Louis, Missouri, United States
RECRUITINGIncidence of Dose Limiting Toxicities
Number of subjects with dose limiting toxicities (DLTs) through dose escalation only.
Time frame: 1 cycle of study treatment (each cycle is 21 days)
Incidence of Treatment Emergent Adverse Events
Number of subjects with treatment-emergent adverse effects through dose escalation and expansion.
Time frame: 36 months
Incidence of Serious adverse events
Number of subjects with Serious Adverse Events through dose escalation and expansion.
Time frame: 36 months
Number of participants with clinical laboratory abnormalities
Time frame: 36 months
Number of participants with vital sign abnormalities
Vitals will be measured in Riva Rocci (RR) in mmHG and Pulse in beats per minute
Time frame: 36 months
Number of participants with electrocardiogram (ECG) abnormalities
ECG will be measured in ECG intervals (QT and QTc with Fridericia correction, and PR), QRS duration, and heart rate will be tested and analyzed.
Time frame: 36 months
ORR per RECIST 1.1
Objective Response Rate (ORR) is defined as the proportion of participants who have a best response of confirmed partial response (PR) or confirmed complete response (CR) to study treatment per RECIST v1.1 by investigator assessment through dose escalation and expansion.
Time frame: 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Zai Lab Site 02002
New York, New York, United States
RECRUITINGZai Lab Site 02006
Fairfax, Virginia, United States
RECRUITINGDuration of Response per RECIST 1.1
Duration of Response is defined as the time from the first assessment of CR or PR to the first assessment of progression disease (PD) by investigator per RECIST 1.1 or death due to any cause (whichever occurs first) through dose escalation and expansion.
Time frame: 36 months
PFS per RECIST 1.1
Progression-Free Survival (PFS) is defined as the time from first dosing date to the first documented PD by investigator per RECIST 1.1 or death for any reasons (whichever occurs first) through dose escalation and expansion.
Time frame: 36 months
DCR per RECIST 1.1
Disease Control Rate (DCR) is defined as the proportion of participants who have a best response of confirmed CR, confirmed PR, or SD per RECIST 1.1 by investigator assessment through dose escalation and expansion.
Time frame: 36 months
PK characteristics of ZL-6201 (ADC conjugate), total antibody
Pharmacokinetics: Total Antibody of ZL-6201
Time frame: 36 months
PK characteristics of ZL-6201 (ADC conjugate), unconjugated payloads
Pharmacokinetics: Unconjugated payloads of ZL-6201
Time frame: 36 month