A Trial of ZL-1201 in Subjects With Advanced Cancer

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

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

Study Overview

• Status: Completed
• Conditions: Advanced Cancer
• Intervention / Treatment: Drug: ZL-1201

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • CN1003
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • CN1002
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85259
      • US2004
  • Florida
    • Jacksonville, Florida, United States, 32224
      • US2005
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • US2001
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • US2003
  • New York
    • New York, New York, United States, 11776
      • US2002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.; Other Names: Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics：AUC	The area under the curve (AUC) of serum concentration of the drug after the administration	Up to 30 days after last dose
Pharmacokinetics: Cmax	Maximum serum concentration(Cmax) of the drug after the administration	Up to 30 days after last dose
Pharmacokinetics: t1/2	Half-life(t1/2) of the drug	Up to 30 days after last dose
Pharmacokinetics: CL	Total body clearance of the drug	Up to 30 days after last dose
Pharmacokinetics: Vss	Volume of the distrubution at steady-state	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	Up to 30 days after last dose
Overall Response Rate (ORR）	ORR includes CR and PR	Up to 2 years after enrollment

Collaborators and Investigators

• Sponsor: Zai Lab (Shanghai) Co., Ltd.
• Investigators: Study Director: Study Physician, Zai Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2020
• Primary Completion (Actual): May 17, 2022
• Study Completion (Actual): January 19, 2023

Study Registration Dates

• First Submitted: January 27, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 6, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Advanced solid tumors or hematologic malignancies
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ZL-1201-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No