Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors

  • STATUS
    Recruiting
  • End date
    Dec 25, 2023
  • participants needed
    218
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 25 January 2021

Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Description

Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.

Details
Condition Advanced Malignancies
Treatment IBI322
Clinical Study IdentifierNCT04328831
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors
At least one evaluable lesion
Male or female subject above 18 years old, no more than 75 years old
Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1
Must have adequate organ function

Exclusion Criteria

Previous exposure to any anti-CD47 monoclonal antibody, SIRP antibody, or CD47/SIRP recombinant protein
Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies
Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
Subjects who have a history of blood transfusion within 2 weeks prior to the study
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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