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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 : Recruiting
First Posted : February 6, 2020
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
Zai Lab (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. )

Tracking Information
First Submitted Date  ICMJE January 27, 2020
First Posted Date  ICMJE February 6, 2020
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE May 11, 2020
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2021)
  • Pharmacokinetics:AUC [ Time Frame: Up to 30 days after last dose ]
    The area under the curve (AUC) of serum concentration of the drug after the administration
  • Pharmacokinetics: Cmax [ Time Frame: Up to 30 days after last dose ]
    Maximum serum concentration(Cmax) of the drug after the administration
  • Pharmacokinetics: t1/2 [ Time Frame: Up to 30 days after last dose ]
    Half-life(t1/2) of the drug
  • Pharmacokinetics: CL [ Time Frame: Up to 30 days after last dose ]
    Total body clearance of the drug
  • Pharmacokinetics: Vss [ Time Frame: Up to 30 days after last dose ]
    Volume of the distrubution at steady-state
  • Immunogenicity [ Time Frame: Up to 30 days after last dose ]
    Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity
  • Overall Response Rate (ORR) [ Time Frame: Up to 2 years after enrollment ]
    ORR includes CR and PR
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2020)
  • 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.
  • Pharmacokinetics: Cmax [ Time Frame: Up to 99 days after first dose ]
    Maximum concentration(Cmax) of the drug after administration
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of ZL-1201 in Subjects With Advanced Cancer
Official Title  ICMJE First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
Brief Summary First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE Drug: ZL-1201
Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
Other Name: Monotherapy
Study Arms  ICMJE Experimental: Single arm, ZL-1201
Single arm, ZL-1201
Intervention: Drug: ZL-1201
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 3, 2021)
66
Original Estimated Enrollment  ICMJE
 (submitted: February 5, 2020)
65
Estimated Study Completion Date  ICMJE January 31, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Study Physician +86 21 6163 2588 ZL-1201-001@zailaboratory.com
Listed Location Countries  ICMJE China,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04257617
Other Study ID Numbers  ICMJE ZL-1201-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Zai Lab (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. )
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Zai Lab (Shanghai) Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Physician Zai Laboratory
PRS Account Zai Lab (Hong Kong), Ltd.
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP