A Study to Evaluate the Safety Tolerability and Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced Lung Cancer

  • STATUS
    Recruiting
  • End date
    Nov 9, 2024
  • participants needed
    20
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 1 March 2021

Summary

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.

Details
Condition Advanced Lung Cancer
Treatment Sintilimab, IBI939
Clinical Study IdentifierNCT04672356
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on1 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Advanced Lung Cancer??
Signed the Informed Consent Form
Male or female 18 and75 years of age
Life expectancy 12 weeks
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements
Histologically or cytologicallyconfirmed non-small cell lung or small cell lung cancer

Exclusion Criteria

Previous exposure to immune-mediated therapy; previous use of antitumor vaccine
Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug
Received any investigational agent within 4 weeks prior to the first dose of study drug
Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose
Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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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