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A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Patients With Advanced Solid Tumors.
Sponsor: Chiome Bioscience Inc.
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.
Official title: A Phase I Study to Assess the Safety, Tolerability and Biomarker Profiles of CBA-1535, Recombinant Protein Tribody in Patients With Previously Treated Advanced Solid Tumors.
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2022-06-27
Completion Date
2026-12
Last Updated
2025-06-12
Healthy Volunteers
No
Conditions
Interventions
CBA-1535
Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.
CBA-1535+Pembrolizumab
Drug：CBA-1535 First Dosing will be determined by Part 1. And dosing will be increased until DLT or disease progression occurs. Drug：Pembrolizumab 200 mg/body
Locations (2)
Shizuoka Cancer Center
Nagaizumicho, Shizuoka, Japan
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan