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

NCT ID: NCT07016997

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1: CBA-1535 (single agent therapy)

Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 of each 21-day cycle.

Group Type: EXPERIMENTAL

CBA-1535

Intervention Type: DRUG

Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.

Part 2: CBA-1535+Pembrolizumab

Patients will receive CBA-1535 as weekly IV infusion at escalated doses on Day 1, 8 and 15 , and Pembrolizumab as Q3W IV infusion at fix dose on Day 1 of each 21-day cycle.

Group Type: EXPERIMENTAL

CBA-1535+Pembrolizumab

Intervention Type: DRUG

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

Interventions

CBA-1535

Dosing is increased from 0.1 µg/body until DLT or disease progression occurs.

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who provide voluntary written informed consent to participate in the study
• ECOG performance status: <= 1
• Patients with 3 months or longer life expectancy
• Patients with solid tumors for whom no standard therapy is available or who are refractory to or intolerant of standard therapy

Exclusion Criteria

• Patients who received other investigational drug or antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment
• Patients who received anti-cancer drug within 14 days prior to enrollment
• Patients with previous or suspected hypersensitivity to protein preparations such as therapeutic antibodies (Chinese hamster ovary cell-derived drugs) or any component of the study drug

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiome Bioscience Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shizuoka Cancer Center

Nagaizumicho, Shizuoka, Japan

Site Status: RECRUITING

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Chiome Bioscience Inc.

Role: CONTACT

ir@chiome.co.jp

+81-3-6383-3561

Other Identifiers

jRCT2031210708

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1535-001

Identifier Type: -

Identifier Source: org_study_id