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

Summary

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.

Eligibility

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

Conditions3

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