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NCT Number: NCT04257617

A Trial of ZL-1201 in Subjects With Advanced Cancer

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

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Key information

Conditions

Advanced Cancer Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CN1003, Chongqing, Chongqing Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ZL-1201

Drug

Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

Other names: Monotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Zai Lab (Shanghai) Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Feb 6, 2020
Registry last updated
Aug 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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