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A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.

RecruitingPhase 1Ages 20 Years - anyAllChiome Bioscience Inc.
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In plain words

What the trial is, and whether it could suit you

This is a First in Human muticenter, non-randomized, open-label Phase I dose-escalation study of CBA-1535. The study will have 2 parts (Part 1 and Part 2). Part 1 is the dose-escalation cohorts of CBA-1535 single agent theapy. Part 2 is the dose-escalation cohorts of CBA-1535 in combination with Pembrlizumab. This study will evaluate the safety, tolerability, PK, biomarker profiles and preliminary efficacy of CBA-1535.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients who provide voluntary written informed consent to participate in the study * ECOG performance status: \<= 1 * Patients with 3 months or longer life expectancy * Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy Exclusion Criteria: * Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment * Patients who received anti-cancer drug within 14 days prior to enrollment * Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug
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What it tests

  • CBA-1535
  • CBA-1535+Pembrolizumab
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Where

2 sites
Shizuoka Cancer Center
Nagaizumicho, Japan
National Cancer Center Hospital
Chuo-Ku, Japan
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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