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A Trial of ZL-1201 in Subjects With Advanced Cancer

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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. )

Study Description
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Brief Summary:
First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: ZL-1201 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: First in Human, Phase I Trial of ZL-1201 in Subjects With Advanced Cancer
Actual Study Start Date : May 11, 2020
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Single arm, ZL-1201
Single arm, ZL-1201
 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


Outcome Measures
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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 30 days after last dose ]
    The area under the curve (AUC) of serum concentration of the drug after the administration

  2. Pharmacokinetics: Cmax [ Time Frame: Up to 30 days after last dose ]
    Maximum serum concentration(Cmax) of the drug after the administration

  3. Pharmacokinetics: t1/2 [ Time Frame: Up to 30 days after last dose ]
    Half-life(t1/2) of the drug

  4. Pharmacokinetics: CL [ Time Frame: Up to 30 days after last dose ]
    Total body clearance of the drug

  5. Pharmacokinetics: Vss [ Time Frame: Up to 30 days after last dose ]
    Volume of the distrubution at steady-state

  6. 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

  7. Overall Response Rate (ORR） [ Time Frame: Up to 2 years after enrollment ]
    ORR includes CR and PR


Eligibility Criteria
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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:

  • 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
Contacts and Locations
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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: Study Physician +86 21 6163 2588 ZL-1201-001@zailaboratory.com

Locations
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United States, Arizona
US2004 Recruiting
Phoenix, Arizona, United States, 85259
United States, Florida
US2005 Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
US2001 Recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
US2003 Recruiting
Saint Louis, Missouri, United States, 63110
United States, New York
US2002 Recruiting
New York, New York, United States, 11776
China, Chongqing
CN1003 Recruiting
Chongqing, Chongqing, China
China, Zhejiang
CN1002 Not yet recruiting
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Zai Lab (Shanghai) Co., Ltd.
Investigators
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Study Director: Study Physician Zai Laboratory
More Information
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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: July 28, 2021
Last Verified: July 2021
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 (Hong Kong), Ltd. ( Zai Lab (Shanghai) Co., Ltd. ):
Advanced solid tumors or hematologic malignancies
Additional relevant MeSH terms:
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Neoplasms