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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04257617
Other study ID # ZL-1201-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date May 11, 2020
Est. completion date January 19, 2023

Study information

Verified date February 2023
Source Zai Lab (Hong Kong), Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date January 19, 2023
Est. primary completion date May 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists. - Adequate hematologic status - Adequate coagulation function - Adequate hepatic function - Adequate renal function Exclusion Criteria: - Known active brain metastases - Red blood cells transfusion dependence - Known cardiopulmonary disease - Pregnant or breast-feeding females - Any other serious underlying medical

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ZL-1201
Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

Locations

Country Name City State
China CN1003 Chongqing Chongqing
China CN1002 Hangzhou Zhejiang
United States US2005 Jacksonville Florida
United States US2002 New York New York
United States US2004 Phoenix Arizona
United States US2001 Rochester Minnesota
United States US2003 Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Zai Lab (Shanghai) Co., Ltd.

Countries where clinical trial is conducted

United States,  China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From the time of informed consent to 30 days after last dose
Secondary Pharmacokinetics:AUC The area under the curve (AUC) of serum concentration of the drug after the administration Up to 30 days after last dose
Secondary Pharmacokinetics: Cmax Maximum serum concentration(Cmax) of the drug after the administration Up to 30 days after last dose
Secondary Pharmacokinetics: t1/2 Half-life(t1/2) of the drug Up to 30 days after last dose
Secondary Pharmacokinetics: CL Total body clearance of the drug Up to 30 days after last dose
Secondary Pharmacokinetics: Vss Volume of the distrubution at steady-state Up to 30 days after last dose
Secondary Immunogenicity Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity Up to 30 days after last dose
Secondary Overall Response Rate (ORR) ORR includes CR and PR Up to 2 years after enrollment
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