Study of IBI318 in Participants With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Dec 30, 2023
  • participants needed
    327
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 23 January 2021

Summary

This study is an open, multicenter, Ia/Ib phase study to evaluate the safety, tolerability, and initial efficacy of IBI318 in the treatment of patients with advanced malignancy.

Details
Condition Advanced Malignancy
Treatment IBI318
Clinical Study IdentifierNCT03875157
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Sign the written informed consent form
Men or women aged 18 years or older
Expected survival time 12 weeks
Tumor assessment according to RECIST v1.1, at least one measurable lesion
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Have adequate organ and bone marrow function
Male participants and female participants must agree to use contraception during the treatment period and within 180 days after the treatment period
Female subjects must not be pregnant, not breastfeeding: have evidence of postmenopausal status, or urine or serum pregnancy tests are negative in premenopausal status
Ia: Subjects with locally advanced, recurrent or metastatic histologically or cytologically confirmed solid tumors or hematologic tumors and refractory or tolerant to existing standard treatments
Ib: Metastatic non-small cell lung cancer, advanced liver cancer, advanced esophageal squamous cell cancer, advanced gastric cancer and other tumors that have been proved by histology or cytology with initial therapeutic effect in Phase Ia

Exclusion Criteria

Previously exposed to immune-therapies including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anti-tumor vaccine
Participating in another interventional clinical study, or an observational (non-interventional) clinical study or a follow-up phase of an interventional study
Receive the last anti-tumor treatment within 4 weeks prior to the first dose of study drug
Use of immunosuppressive drugs within 4 weeks prior to the first dose of study drug
Require long-term steroid therapy or any other form of immunosuppressive therapy not including inhaled steroids
In 4 weeks prior to the first dose of study drug, there was toxicity (excluding hair loss or fatigue) caused by previous antitumor therapy that did not recover to NCI CTCAE v5.0 level 0-1 or level as the inclusion criteria
Received major surgery or has unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose of study drug
Expect to receive other anti-tumor treatments during study (allowing palliative radiotherapy)
History of infectious) pneumonitis that required steroids or has current pneumonitis
Known active untreated CNS metastases and/or spinal cord compression and/or cancerous meningitis, or with a history of soft meningeal cancer
Active autoimmune disease that has required systemic treatment in past 2 years
Known active Hepatitis B or Hepatitis C virus
Uncontrolled concomitant diseases or neurological, psychiatric/social conditions that affect the compliance to the study, significantly increase the risk of adverse events, or affect the subject's ability to provide written informed consent
Known history of human immunodeficiency virus (HIV) infection
Known history of active tuberculosis (TB; Bacillus tuberculosis) or active syphilis
History of allogeneic organ transplantation and hematopoietic stem cell transplantation
Accompanied by uncontrolled third interstitial fluids requiring repeated drainage, such as pleural effusion, ascites, pericardial effusion, etc
Known severe allergic reactions to other monoclonal antibodies or are allergic to any IBI318 formulation component
Female subjects during pregnancy or lactation
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How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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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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