A Trial of ZL-1201 in Subjects With Advanced Cancer

  • STATUS
    Recruiting
  • participants needed
    65
  • sponsor
    Zai Lab (Shanghai) Co., Ltd.
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Updated on 16 February 2024
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Summary

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

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.

Details
Condition Locally Advanced Solid Tumor
Age 18years - 100years
Treatment ZL1201
Clinical Study IdentifierNCT04257617
SponsorZai Lab (Shanghai) Co., Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
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