A Trial of ZL-1201 in Subjects With Advanced Cancer

Advanced Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04257617
• Other study ID #: ZL-1201-001
• Status: Completed
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

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