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

Launched by CHIOME BIOSCIENCE INC. · Jun 4, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CBA-1535, designed to help patients with advanced solid tumors, especially those whose cancer has not responded to standard therapies. The trial has two parts: the first part will look at CBA-1535 alone, while the second part will test CBA-1535 in combination with another drug called Pembrolizumab. The main goals of this study are to evaluate how safe the treatment is, how well it works, and how the body processes the drug.

To participate in this trial, patients must be at least 18 years old and have a life expectancy of at least three months. They should have solid tumors for which there are no standard treatment options available, or they may have had negative reactions to existing treatments. Participants will need to provide written consent to join the study and will be monitored closely for side effects and other important health information throughout the trial. This study is currently recruiting participants and is open to all genders.

Gender

ALL

Eligibility criteria

• 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