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A Trial of ZL-1201 in Subjects With Advanced Cancer

Sponsor
Zai Lab (Shanghai) Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04257617
Collaborator
(none)
66
Enrollment
7
Locations
1
Arm
44.7
Anticipated Duration (Months)
9.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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 Names:
  • Monotherapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety and tolerability of ZL-1201 when administered as an intravenous (IV) infusion: Incidence of Treatment-Emergent Adverse Events [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 [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 [Up to 30 days after last dose]

      Maximum serum concentration(Cmax) of the drug after the administration

    3. Pharmacokinetics: t1/2 [Up to 30 days after last dose]

      Half-life(t1/2) of the drug

    4. Pharmacokinetics: CL [Up to 30 days after last dose]

      Total body clearance of the drug

    5. Pharmacokinetics: Vss [Up to 30 days after last dose]

      Volume of the distrubution at steady-state

    6. Immunogenicity [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） [Up to 2 years after enrollment]

      ORR includes CR and PR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 US2004 Phoenix Arizona United States 85259
    2 US2005 Jacksonville Florida United States 32224
    3 US2001 Rochester Minnesota United States 55905
    4 US2003 Saint Louis Missouri United States 63110
    5 US2002 New York New York United States 11776
    6 CN1003 Chongqing Chongqing China
    7 CN1002 Hangzhou Zhejiang China

    Sponsors and Collaborators

    • Zai Lab (Shanghai) Co., Ltd.

    Investigators

    • Study Director: Study Physician, Zai Laboratory

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zai Lab (Shanghai) Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT04257617
    Other Study ID Numbers:
    • ZL-1201-001
    First Posted:
    Feb 6, 2020
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.
    Advanced solid tumors or hematologic malignancies
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Jul 28, 2021