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A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

NCT05360680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-01-22

No results posted yet for this study

Summary

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102 intravenous (IV) monotherapy in HLA-A\*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.

Conditions

Interventions

DRUG

CUE-102

CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.

Sponsors & Collaborators

  • Cue Biopharma

    lead INDUSTRY

Principal Investigators

  • Matteo Levisetti, MD · Cue Biopharma

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-14
Primary Completion
2025-03-12
Completion
2025-03-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05360680 on ClinicalTrials.gov