NCT07016997

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Chiome Bioscience Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To evaluate safety and efficacy of CBA-1535 in the following two parts in a stepwise manner: Part 1 \- In Part 1, the primary objective is to evaluate the safety and tolerability of CBA-1535 in patients with solid tumors where no standard treatment is available, or who are intolerant to or non-responders to standard treatments. Additionally, the PK, biomarker profiles, and preliminary efficacy will be evaluated. The initial dose for Part 2 will also be determined. Part 2 \- In Part 2, The primary objective is to evaluate the safety and tolerability of CBA-1535 in combination with pembrolizumab in patients with solid tumor where no standard treatment is available, or who are intolerable or non-responder to the standard treatment. Additionally, the PK, biomarker profiles, preliminary efficacy will be evaluated. The recommended Phase 2 dose (R2PD) will also be determined.

Conditions

• Solid Tumors
• Refractory Cancer

Interventions

Type	Name	Description
DRUG	CBA-1535	Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.
DRUG	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

Timeline

• Start date: 2022-06-27
• Primary completion: 2025-12-31
• Completion: 2026-12-01
• First posted: 2025-06-12
• Last updated: 2025-06-12

Locations

2 sites across 1 country: Japan