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

NCT07016997 | Recruiting Phase 1

• 2 other identifiers: 1535-001jRCT2031210708
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumors; Refractory Cancer

Keywords

CBA-1535; 5T4; CD3; T cell Engager; Trophoblast Glycoprotein; Tribody; solid tumors

Outcome Measures

Primary Outcomes (2)

• Dose limiting toxicity

  DLTs are assessed according to CTCAE v.5.0 during the first cycle (21 days).

  Up to 21 days in Cycle 1

• Adverse event

  An adverse event is any untoward or unintended sign, symptom, or disease in a subject administered an investigational product, regardless of whether or not it is related to the investigational product.

  Up to approximately 24 months

Secondary Outcomes (2)

• Serum CBA-1535 concentration

  From Day 1 to Day 22

• Efficacy in previously treated advanced solid Tumors.

  Up to approximately 24 months.

Study Arms (2)

Part 1: CBA-1535 (single agent therapy)

EXPERIMENTAL

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

Drug: CBA-1535

Part 2: CBA-1535+Pembrolizumab

EXPERIMENTAL

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.

Drug: CBA-1535+Pembrolizumab

Interventions

CBA-1535 DRUG

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

Part 1: CBA-1535 (single agent therapy)

CBA-1535+Pembrolizumab 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

Part 2: CBA-1535+Pembrolizumab

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiome Bioscience Inc.: lead

Study Sites (2)

Shizuoka Cancer Center

Nagaizumicho, Shizuoka, Japan

RECRUITING

National Cancer Center Hospital

Chuo-Ku, Tokyo, Japan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Chiome Bioscience Inc.

CONTACT

+81-3-6383-3561; ir@chiome.co.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: June 12, 2025
• Study Start: June 27, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)