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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.

NCT07016997 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-06-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Chiome Bioscience Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Japan

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016997 on ClinicalTrials.gov