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

Official title

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.

Overview

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.

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

Primary outcome measures

• Dose limiting toxicity [Time frame: Up to 21 days in Cycle 1]
• Adverse event [Time frame: Up to approximately 24 months]

Secondary outcome measures (2)

• Serum CBA-1535 concentration [Time frame: From Day 1 to Day 22]
• Efficacy in previously treated advanced solid Tumors. [Time frame: Up to approximately 24 months.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

Japan · 2 centers

• Shizuoka Cancer Center — Nagaizumicho
• National Cancer Center Hospital — Chuo-Ku

Identifiers

NCT: NCT07016997 · 1535-001 · jRCT2031210708

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗