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A Trial of ZL-1201 in Subjects With Advanced Cancer

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: NCT04257617
Recruitment Status : Not yet recruiting
First Posted : February 6, 2020
Last Update Posted : February 6, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Zai Lab (Shanghai) Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Locally Advanced Solid Tumor Drug: ZL1201 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human, Phase I Trial of Anti-CD47 Antibody ZL-1201 in Subjects With Advanced Cancer
Estimated Study Start Date : April 30, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024

Arm Intervention/treatment
Experimental: Single arm, CD47 monotherapy
Single arm, CD47 monotherapy
Drug: ZL1201
Part 1 and Part 2: Escalating dose of ZL-1201 IV weekly, Part 3: three highest dose levels determined from Part 2.
Other Name: CD47 monotherapy




Primary Outcome Measures :
  1. 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 ]
    Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0


Secondary Outcome Measures :
  1. Pharmacokinetics:AUC [ Time Frame: Up to 99 days after first dose ]
    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.

  2. Pharmacokinetics: Cmax [ Time Frame: Up to 99 days after first dose ]
    Maximum concentration(Cmax) of the drug after administration

  3. Immunogenicity [ Time Frame: Up to up to 99 days after first dose ]
    Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity

  4. Overall Response Rate (ORR) [ Time Frame: Up to 2 years after enrollment ]
    ORR includes CR and PR assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma



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

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): NCT04257617


Contacts
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Contact: Zai Lab +86 21 6163 2588 ZL-1201-001@zailaboratory.com

Sponsors and Collaborators
Zai Lab (Shanghai) Co., Ltd.
PPD
Investigators
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Principal Investigator: Alex A Adjei, PhD Mayo Clinic College of Medicine and Science

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Responsible Party: Zai Lab (Shanghai) Co., Ltd.
ClinicalTrials.gov Identifier: NCT04257617    
Other Study ID Numbers: ZL-1201-001
First Posted: February 6, 2020    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
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
Keywords provided by Zai Lab (Shanghai) Co., Ltd.:
solid tumors and hematologic malignancies
anti-CD47 antibody
Additional relevant MeSH terms:
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Antibodies
Immunologic Factors
Physiological Effects of Drugs