Study of IBI323 in Patients With Advanced Malignancies

  • STATUS
    Recruiting
  • End date
    Mar 9, 2023
  • participants needed
    322
  • sponsor
    Innovent Biologics (Suzhou) Co. Ltd.
Updated on 18 September 2021

Summary

The purpose of this study is to evaluate safety, tolerability and efficacy of IBI323(anti-LAG-3/PD-L1) or in combination with chemotherapy in participants with advanced malignancies. Another purpose is to determine the pharmacokinetics,pharmacodynamics and immunogenicity of IBI323

Details
Condition Advanced Malignancies
Treatment IBI323
Clinical Study IdentifierNCT04916119
SponsorInnovent Biologics (Suzhou) Co. Ltd.
Last Modified on18 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Phase Ia Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment Phase Ib cohort A Patients with IO-refractory advanced NSCLC cohort B Patients with IO-naive advanced NSCLC who have failed standard treatment cohort C Patients with advanced NSCLC who have no prior treatment and PD-L1 TPS1% cohort D Patients with ES-SCLC or G3 neuroendocrine tumors who have failed standard treatment cohort E Patients with advanced MPM who have failed standard treatment cohort F Patients with advanced UC who have failed standard treatment cohort G Patients with advanced nccRCC who have failed standard treatment cohort H Patients with advanced HCC who have failed standard treatment cohort I Patients with advanced NPC who have failed standard treatment cohort J Patients with advanced CC or HNSCC who have failed standard treatment cohort K Patients with advanced GC or GEJC with HER2 negative who have no prior treatment cohort L Patients with advanced TNBC who have failed standard treatment
Able to understand and willing to sign the ICF
18 to 75 years old
Life expectancy at least 12 weeks
At least 1 measurable lesion per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ and bone marrow functionAdequate organ and bone marrow function

Exclusion Criteria

Prior treatment with any anti- LAG-3 antibody
Prior immunotherapy treatment for Stage Ia extension cohort ( immunotherapy untreated) and Stage Ib cohort B-L
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
Symptomatic CNS metastasis
History of autoimmune disease , present active autoimmune disease or inflammatory diseases
Pregnant or nursing females
Clear my responses

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Step 1 Connect with a study center
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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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