OncoC4, Inc.
ONC-783-001 is a Phase I open label, dose-escalation study for evaluating the safety, pharmacokinetics (PK) and efficacy of ONC-783 as a single agent in patients with advanced/metastatic solid tumors, focusing on colorectal cancer, ovarian cancer, pancreatic cancer, or breast cancer.
This is a first in human study on a novel bispecific antibody, ONC-783, targeting cancer specific neoantigen CD24 on tumor cells and CD3 on T cells. CD24 is over-expressed in about 70% of solid tumors and hematological malignancies. CD24 overexpression is associated with poor prognosis. Cancer-specific neo-CD24 epitope will distinguish malignant CD24 from physiological CD24. This study is a multi-level dose escalation study with ONC-783 to test the safety, PK, and efficacy in patients with solid tumors.
Inclusion Criteria: * Age ≥ 18 yrs old. * Male or Female * Must have ECOG score ≤ 1. The body weight should be ≥40 kg. The life expectance should be estimated ≥ 12 weeks. * A histological or cytological diagnosis of metastatic or locally advanced pancreatic cancer, ovarian cancer, colorectal cancer, or breast cancer. * Must have measurable target lesion according to RECIST V1.1. * Adequate organ function as determined by laboratory tests. * Voluntary agreement to participate as evidenced by written informed consent. * Female patient of childbearing potential: negative pregnancy test and agree…
ONC-783 is a bispecific humanized monoclonal antibody targeting CD24 and CD3.
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