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

Recruiting now · Phase 1

Conditions studied: Solid Tumors, Refractory Cancer

In brief

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.

Key facts

Study ID

NCT07016997

Run by

Chiome Bioscience Inc.

People needed

70

Starts

2022-06-27

Expected to finish

2026-12-01

Last updated by the study team

2025-06-12

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shizuoka Cancer Center — Nagaizumicho, Shizuoka, Japan (enrolling)
• National Cancer Center Hospital — Chuo-Ku, Tokyo, Japan (enrolling)

Full record on ClinicalTrials.gov

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