Clinical Trial

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

Recruiting Phase 1
View on ClinicalTrials.gov →
Record status
This record was last updated June 12, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07016997
Lead Sponsor Chiome Bioscience Inc.
Conditions Solid Tumors, Refractory Cancer
Enrollment 70 participants
Start Date 2022-06-27
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2025-06-12