A Study of ZL-1211 in Patients With Advanced Solid Tumor

August 28, 2024 updated by: Zai Biopharmaceutical (Suzhou) Co., Ltd.

A Phase I, First-in-Human, Open-Label, Dose Escalation Study of ZL- 1211 in Patients With Unresectable or Metastatic Solid Tumor

This study is a Phase I/II, open-label, dose escalation, and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of ZL-1211 administered by IV infusion on a every 2 weeks (Q2W) schedule.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study consists of two stages, Phase I -Dose Escalation Phase to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211, and Phase II -Cohort Expansion Phase to further define the safety and initial antitumor activity of ZL-1211 with the dose established in the Dose Escalation Phase. The trial was intended to be a Phase 1/2 trial but the Phase 2 was not initiated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230031
        • Zai Lab Site 1725
    • Beijing
      • Beijing, Beijing, China, 100032
        • Zai Lab Site 1548
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Zai Lab Site 1551
    • Henan
      • Zhengzhou, Henan, China, 450003
        • Zai Lab Site 1549
      • Zhengzhou, Henan, China, 450052
        • Zai Lab Site 1202
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Zai Lab Site 1537
    • Shandong
      • Jinan, Shandong, China, 250014
        • Zai Lab Site 1539
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Zai Lab Site 1542
    • Sichuan
      • Chengdu, Sichuan, China, 610044
        • Zai Lab Site 1712
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Zai Lab Site 1529
      • Hangzhou, Zhejiang, China, 310014
        • Zai Lab Site 1714
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Zai Lab Site 2012
    • California
      • Lynwood, California, United States, 90262
        • Zai Lab Site 2016
    • Indiana
      • Indianapolis, Indiana, United States, 46250
        • Zai Lab Site 2014
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Zai Site 2020
    • New York
      • New York, New York, United States, 10016
        • Zai Lab Site 2025
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Zai Lab Site 2015
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Zai Lab Site 2011
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Zai Lab Site 2023
    • Washington
      • Spokane, Washington, United States, 99208
        • Zai Lab Site 2013
      • Tacoma, Washington, United States, 98405
        • Zai Lab Site 2022

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients are eligible to be included in the study only if all the following inclusion criteria apply:

  1. Adults≥ 18 years of age.
  2. Willing and able to provide signed and dated informed consent prior to any study related procedures and willing and able to comply with all study procedures.
  3. All patients from Phase I and Phase II are required to provide tumor tissue for CLDN18.2 IHC assessment, and only patients with CLDN18.2-positive tumors will be included in this study.
  4. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumors, refractory to standard treatment
  5. Evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

  7. Adequate hepatic function

    1. Total bilirubin ≤ 1.5 × upper limit of normal (ULN).
    2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; AST or ALT ≤ 5 × ULN if liver metastases are present.
  8. Adequate renal function, as defined by serum creatinine < 1.5 × ULN OR calculated creatinine CL > 40 mL/min, Cockroft-Gault Equation:

  9. Hematological function defined as:

    1. Absolute neutrophil count ≥ 1.5 × 109/L without growth factor support in the 2 weeks prior to screening.
    2. Platelet count ≥ 100 × 109/L without transfusion in the 2 weeks prior to screening.
    3. Hemoglobin ≥ 9 g/dL without transfusion in the 2 weeks prior to screening.
  10. Prothrombin time, international normalized ratio or/and activated partial thromboplastin time < 1.5 × ULN.
  11. Recovery, to Grade 0-1, from AEs related to prior anticancer therapy except alopecia, < Grade 2 sensory neuropathy, lymphopenia.

Exclusion Criteria:

  1. Patient with known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome related illness or known active or chronic hepatitis B virus infection or hepatitis C virus.
  2. Any uncontrolled active infection.
  3. Previous exposure to any CLDN18.2 antibody or CLDN18.2 chimeric antigen receptor T cell therapy.
  4. Newly diagnosed or symptomatic brain metastases anticonvulsants are allowed.
  5. Severe cardiovascular disease; New York Heart Association Class II-IV heart failure within 6 months of screening; uncontrolled arrhythmia within 6 months of screening.
  6. Anticancer therapy or radiation therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to screening; palliative radiotherapy within 2 weeks prior to screening.
  7. Major surgery within 4 weeks prior to first dose; minor surgery within 2 weeks prior to first dose.
  8. Symptomatic intrinsic lung disease (chronic obstructive pulmonary disease, pulmonary fibrosis).

  9. Gastrointestinal abnormalities including:

    1. Documented unresolved gastric outlet obstruction or persistent vomiting defined as ≥ 3 episodes within 24 hours.
    2. Active peptic ulcer disease required treatment in the past 3 months.
    3. Gastrointestinal bleeding as evidenced by hematemesis, hematochezia, or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy.
    4. Documented active colitis within 4 weeks prior to study entry, including infectious colitis, radiation colitis and ischemic colitis.
    5. History of ulcerative colitis or Crohn's disease.
  10. Patient has received systemic immunosuppressive therapy, including systemic corticosteroids 2 weeks prior to first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ZL-1211 monotherapy
Drug: ZL-1211
Phase 1 dose escalation part will enroll about 12-42 patients, Phase 2 dose expansion part will enroll about 15-40 patients in each cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase I ：MTD or MAD
Time Frame: One month
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) (if no MTD is defined) of ZL-1211
One month
Phase I and Phase II: safety and tolerability
Time Frame: Approximately 10 months
Incidence of Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Approximately 10 months
Phase II: preliminary antitumor activity
Time Frame: Approximately 10 months
Objective response rate defined as the proportion of patients with partial response (PR) proportion of patients with partial response (PR) or complete response (CR) based on Investigator assessment of tumor lesions per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Approximately 10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase I and Phase II: pharmacokinetics (PK):AUC
Time Frame: Approximately 10 months
Area under the curve (AUC)
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Cmax
Time Frame: Approximately 10 months
Maximum serum concentration (Cmax)
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Tmax
Time Frame: Approximately 10 months
Time to reach Cmax (Tmax)
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Ctrough
Time Frame: Approximately 10 months
Ctrough
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):Vss
Time Frame: Approximately 10 months
Volume of distribution at steady state (Vss)
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):CL
Time Frame: Approximately 10 months
Clearance (CL)
Approximately 10 months
Phase I and Phase II: pharmacokinetics (PK):t1/2
Time Frame: Approximately 10 months
Half-life (t1/2)
Approximately 10 months
Phase I and Phase II: immunogenicity
Time Frame: Approximately 10 months
Incidence of anti-drug antibodies (ADAs)
Approximately 10 months
Phase I and Phase II: immunogenicity
Time Frame: Approximately 10 months
Quantity of anti-drug antibodies (ADAs)
Approximately 10 months
Phase II: preliminary antitumor activity
Time Frame: Approximately 10 months
Duration of response (DOR), defined as the time from the first date of objective response (CR or PR) to the first documented date of disease progression per RECIST v1.1 or the date of death due to any cause, whichever occurs first
Approximately 10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zai Biopharmaceutical (Suzhou) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 9, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 9, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZL-1211-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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