Clinical Trials /

A Trial of ZL-1201 in Subjects With Advanced Cancer

NCT04257617

Description:

First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Trial of ZL-1201 in Subjects With Advanced Cancer
  • Official Title: First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects With Advanced Cancer

Clinical Trial IDs

  • ORG STUDY ID: ZL-1201-001
  • NCT ID: NCT04257617

Conditions

  • Locally Advanced Solid Tumor

Interventions

DrugSynonymsArms
ZL1201CD47 monotherapySingle arm, CD47 monotherapy

Purpose

First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects with Advanced Cancer

Detailed Description

      This is a first-in-human, dose escalation trial of an anti-CD47 antibody. 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. This study The study is composed of 3
      stages: Part 1 low dose group, and Part 2 high dose group. Part 3 pharmacodynamic (PD)/ dose
      expansion cohort will open after the completion of Part 1 and 2.
    

Trial Arms

NameTypeDescriptionInterventions
Single arm, CD47 monotherapyExperimentalSingle arm, CD47 monotherapy
  • ZL1201

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed advanced solid malignancy or
             Lymphoma

          -  Relapsed or refractory disease after at least 1 prior systemic treatment for the
             primary malignancy and not a candidate for other curative treatment.

          -  Adequate hematologic status

          -  Adequate coagulation function

          -  Adequate hepatic function

          -  Adequate renal function

        Exclusion Criteria:

          -  Known primary tumors of central nervous system disease

          -  Known active brain metastases

          -  Red blood cells transfusion dependence

          -  Known cardiopulmonary disease

          -  Pregnant or breast-feeding females

          -  Any other serious underlying medical
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Pharmacokinetics:AUC
Time Frame:Up to 99 days after first dose
Safety Issue:
Description:The area under the curve (AUC) of serum concentration of the drug after the administration For part 2 and 3 patients, PK will be obtained at the following timepoints: prior to infusion, 0 and 24 hours after 1st EOI ; prior to infusion, 0, 1, 2, 4, 24 and 72 hours after 2nd EOI; prior to infusion, 0, 1, 2, 4 and 24 hours after 8th EOI; additional PK will be assessed prior to infusion on Cycle 1 Day 15, C2D1, C2D15, C2D26~28, C3D1, C3D22 and C4D15.
Measure:Pharmacokinetics: Cmax
Time Frame:Up to 99 days after first dose
Safety Issue:
Description:Maximum concentration(Cmax) of the drug after administration
Measure:Immunogenicity
Time Frame:Up to up to 99 days after first dose
Safety Issue:
Description:Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity
Measure:Overall Response Rate (ORR)
Time Frame:Up to 2 years after enrollment
Safety Issue:
Description:ORR includes CR and PR assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Zai Lab (Shanghai) Co., Ltd.

Trial Keywords

  • solid tumors and hematologic malignancies
  • anti-CD47 antibody

Last Updated

June 10, 2020