Actively Recruiting
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Led by Chiome Bioscience Inc. · Updated on 2025-06-12
70
Participants Needed
2
Research Sites
231 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who provide voluntary written informed consent to participate in the study
- ECOG performance status of 0 or 1
- Patients with a life expectancy of 3 months or longer
- Patients with solid tumors for whom no standard therapy is available, or who are refractory to or intolerant of standard therapy
You will not qualify if you...
- Patients who received other investigational drugs or antibody drugs, including immune checkpoint inhibitors, within 28 days prior to enrollment
- Patients who received anti-cancer drugs within 14 days prior to enrollment
- Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies or any component of the study drug
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shizuoka Cancer Center
Nagaizumicho, Shizuoka, Japan
Actively Recruiting
2
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan
Actively Recruiting
Research Team
C
Chiome Bioscience Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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