A Phase 1 interventional study of ZL-1201 in Advanced Cancer, sponsored by Zai Lab (Shanghai) Co., Ltd.. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Zai Lab (Shanghai) Co., Ltd. · Phase 1, Interventional, and Treatment
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
9,365 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Zai Lab (Shanghai) Co., Ltd. is the lead sponsor of 24 studies on the registry; 8 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single arm, ZL-1201
Drug: ZL-1201
Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
Also known as: Monotherapy
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0
Time frame: From the time of informed consent to 30 days after last dose
Pharmacokinetics：AUC
The area under the curve (AUC) of serum concentration of the drug after the administration
Time frame: Up to 30 days after last dose
Pharmacokinetics: Cmax
Maximum serum concentration(Cmax) of the drug after the administration
Time frame: Up to 30 days after last dose
Pharmacokinetics: t1/2
Half-life(t1/2) of the drug
Time frame: Up to 30 days after last dose
Pharmacokinetics: CL
Total body clearance of the drug
Time frame: Up to 30 days after last dose
Pharmacokinetics: Vss
Volume of the distrubution at steady-state
Time frame: Up to 30 days after last dose
Immunogenicity
Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity
Time frame: Up to 30 days after last dose
Overall Response Rate (ORR）
ORR includes CR and PR
Time frame: Up to 2 years after enrollment
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Zai Lab (Shanghai) Co., Ltd.