A Study Evaluating the Safety Tolerability and Initial Efficacy of Recombinant Human Anti-T-cell Immunoreceptor With Ig and ITIM Domains (TIGIT) Monoclonal Antibody Injection (IBI939) in Subjects With Advanced Malignant Tumors

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    270
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 27 January 2021

Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of IBI939 in subjects with advanced malignancies

Details
Condition Advanced Malignancies
Treatment IBI939, IBI939+ Sintilimab
Clinical Study IdentifierNCT04353830
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Able to understand and willing to sign the ICF
Adults 18 years of age or older
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Life expectancy at least 12 weeks
Adequate organ and bone marrow function
Eligibility Criteria
Previous exposure to any anti-TIGIT antibody
Participate in another interventional clinical study, except for the observational (non-interventional) clinical study or the survival follow-up phase of the interventional study
Any investigational drugs received within 4 weeks prior to the first study treatment
Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy
Immunosuppressive drugs were used within 4 weeks prior to the first administration of the study drug
Medication requiring long-term systemic hormones or any other immunosuppression therapy
Major surgical procedures (craniotomy, thoracotomy, or laparotomy) or unhealed wounds, ulcers, or fractures were performed within 4 weeks prior to the first dose of study therapy
Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases, or leptomeningeal disease
History of autoimmune disease , present active autoimmune disease or inflammatory diseases
Positive human immunodeficiency virus (HIV) test
Active hepatitis B or C, or tuberculosis
History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
Known history of hypersensitivity to any components of the IBI939 or Sintilimab
Pregnant or nursing females
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