A Trial of ZL-1201 in Subjects With Advanced Cancer

Phase 1

Completed

• Conditions: Advanced Cancer
• Interventions: Drug: ZL-1201

• Registration Number: NCT04257617
• Lead Sponsor: Zai Lab (Shanghai) Co., Ltd.

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-02-05
• Study First Posted: 2020-02-06
• Study Start: 2020-05-11
• Primary Completion: 2022-05-17
• Study Completion: 2023-01-19
• Status Verified: 2023-02
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm, ZL-1201	ZL-1201	Single arm, ZL-1201

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events	From the time of informed consent to 30 days after last dose	Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

Secondary Outcome Measures

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

Trial Locations

Locations (7)

US2002; 🇺🇸 New York, New York, United States

US2001; 🇺🇸 Rochester, Minnesota, United States

CN1003; 🇨🇳 Chongqing, Chongqing, China

US2005; 🇺🇸 Jacksonville, Florida, United States

US2003; 🇺🇸 Saint Louis, Missouri, United States

CN1002; 🇨🇳 Hangzhou, Zhejiang, China

US2004; 🇺🇸 Phoenix, Arizona, United States