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A Phase 1 Study of ZL-1218 in Subjects With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05859464
Recruitment Status : Recruiting
First Posted : May 16, 2023
Last Update Posted : May 16, 2023
Zai Biopharmaceutical (Suzhou) Co., Ltd.
Information provided by (Responsible Party):
Zai Lab (Hong Kong), Ltd.

Brief Summary:
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ZL-1218 as a single agent and as combination therapy in subjects with advanced solid tumor malignancies.

Condition or disease Intervention/treatment Phase
Malignant Solid Tumor Drug: ZL-1218 Drug: Pembrolizumab Phase 1

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Study Type : Interventional
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-label, Multicenter Study of ZL-1218 as a Single Agent and as Combination Therapy With Anti-PD-1 Antibody to Evaluate the Safety, Tolerability, and Pharmacokinetics in Subjects With Advanced Solid Tumor Malignancies
Estimated Study Start Date : May 31, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ZL-1218 Drug: ZL-1218
ZL-1218 dose escalation

Experimental: ZL-1218 in combination with Pembrolizumab Drug: ZL-1218
ZL-1218 dose escalation

Drug: Pembrolizumab
Combination treatment with ZL-1218

Primary Outcome Measures :
  1. Incidence of Dose Limiting Toxicities [ Time Frame: Approximately 24 months ]
    Number of subjects with dose limiting toxicities (DLTs)

  2. Incidence of Treatment Related Adverse Events [ Time Frame: Approximately 24 months ]
    Number of subjects with treatment-emergent adverse effects

  3. Incidence of Serious adverse events [ Time Frame: Approximately 24 months ]
    Number of subjects with Serious Adverse Events

  4. Clinically Significant changes in safety assessments [ Time Frame: Approximately 24 months ]
    Changes in safety assessment parameters (e.g., vital signs, electrocardiograms [ECGs], and clinical laboratory results) .

Secondary Outcome Measures :
  1. ORR per RECIST 1.1 [ Time Frame: up to 24 months ]
    Objective Response Rate (ORR) per RECIST 1.1

  2. ORR per iRECIST [ Time Frame: up to 24 months ]
    Objective Response Rate (ORR) per iRECIST

  3. Duration of Response per RECIST 1.1 [ Time Frame: up to 24 months ]
    Duration of Response per RECIST 1.1

  4. Duration of Response per iRECIST [ Time Frame: up to 24 months ]
    Duration of Response per iRECIST

  5. PFS per RECIST 1.1 [ Time Frame: up to 24 months ]
    Progression-Free Survival (PFS) per RECIST 1.1

  6. PFS per iRECIST [ Time Frame: up to 24 months ]
    Progression-Free Survival (PFS) per iRECIST

  7. DCR per RECIST 1.1 [ Time Frame: up to 24 months ]
    Disease Control Rate (DCR) per RECIST 1.1

  8. DCR per iRECIST [ Time Frame: up to 24 months ]
    Disease Control Rate (DCR) per iRECIST

  9. Overall Survival [ Time Frame: up to 24 months ]
    Overall Survival (OS)

  10. Pharmacokinetics (PK): AUC [ Time Frame: up to 24 months ]
    Area under curve (AUC)

  11. Pharmacokinetics (PK): Cmax [ Time Frame: up to 24 months ]
    Maximum serum concentration (CMax)

  12. Pharmacokinetics (PK): Tmax [ Time Frame: up to 24 months ]
    Time to reach Cmax (Tmax)

  13. Pharmacokinetics (PK): Ctrough [ Time Frame: up to 24 months ]

  14. Pharmacokinetics (PK): Vss [ Time Frame: up to 24 months ]
    Volume of distribution as steady state (Vss)

  15. Pharmacokinetics (PK): CL [ Time Frame: up to 24 months ]
    Clearance (CL)

  16. Pharmacokinetics (PK): t1/2 [ Time Frame: up to 24 months ]
    Half-life (t1/2)

  17. Immunogenicity [ Time Frame: up to 24 months ]
    Incidence of anti-drug antibodies (ADAs)

  18. Immunogenicity [ Time Frame: up to 24 months ]
    Quantity of anti-drug antibodies (ADAs)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult men and women ≥ 18 years of age. If 18 years is not the age of majority, then adult men and women ≥ age of majority per local regulation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Subjects must have histologically confirmed and documented diagnosis of locally advanced unresectable or metastatic advanced solid tumor that is refractory to standard treatment, or intolerant to standard treatment, or for which no standard treatment exists.
  • Subjects must have at least one target lesion as defined by RECIST v1.1 on CT, PET/CT, or MRI scan.
  • Subjects must have a site of disease which is safe and amenable to biopsy per the treating institution's guidelines. Subjects must be willing to undergo a tumor biopsy at screening and on treatment, per the protocol guidelines.

Exclusion Criteria:

  • Symptomatic or uncontrolled brain metastasis requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
  • Prior exposure to CCR8 inhibitor (anti-CCR8 antibody) or hypersensitivity to any ingredient of the study drug.
  • Out of range value at screening and before the first dose of study treatment
  • Subjects have received a live vaccine within 30 days of planned start of study therapy.
  • Subjects with known history of, or any evidence of active, non-infectious pneumonitis.
  • Impaired cardiac function or clinically significant cardiac disease within the last 3 months before administration of the first dose of the study drug
  • Treatment with any systemic anti-cancer treatment (including investigational products) within 4 weeks before first dose of study drug
  • Non-palliative radiotherapy within 4 weeks prior to first dose of study drug
  • Major surgery within 4 weeks of the first dose of study drug
  • Infections requiring systemic antibiotic therapy.
  • Any medical conditions that would, in the investigator's judgement, prevent the subject's participation in the clinical study due to safety concerns, compliance with the study procedures, or interpretation of the study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05859464

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Contact: Zai Lab 1218-001 Study Team 6502316519 ZL-1218-001@zailaboratory.com

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United States, New Jersey
Zai Lab Site 2001 Not yet recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Zai Lab Site 2002 Not yet recruiting
New York, New York, United States, 10029
United States, Washington
Zai Lab Site 2003 Recruiting
Spokane, Washington, United States, 99208
Sponsors and Collaborators
Zai Lab (Hong Kong), Ltd.
Zai Biopharmaceutical (Suzhou) Co., Ltd.
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Responsible Party: Zai Lab (Hong Kong), Ltd.
ClinicalTrials.gov Identifier: NCT05859464    
Other Study ID Numbers: Zl-1218-001
First Posted: May 16, 2023    Key Record Dates
Last Update Posted: May 16, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action