Advanced Cancer Clinical Trial
Official title:
First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
Verified date | February 2023 |
Source | Zai Lab (Hong Kong), Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Zai Lab (Shanghai) Co., Ltd. |
United States, China,
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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