Early Clinical Trial Delivers Promising Results for New Bispecific Antibody in Advanced Solid Tumors
DRESDEN, Germany – The Early Clinical Trial Unit (ECTU) at NCT/UCC Dresden has announced the results of a first-in-human clinical trial evaluating the novel bispecific T-cell engager (TCER), IMA401, in 61 patients with advanced solid tumors. The therapy targets the tumor antigen MAGEA4/8 and the CD3 molecule on T cells.
Study Objectives and Design
The primary objectives of the trial were to evaluate the safety profile of IMA401 and determine the optimal dose for future clinical development. Patients received IMA401 as an infusion, with some receiving it in combination with pembrolizumab.
Safety Profile
The most common treatment-related side effects observed were manageable and predictable:
- Cytokine release syndrome (CRS) : Reported in 38% of patients, characterized by grade 1-2 fever.
- Lymphopenia: Occurred in 33% of patients.
- Reversible neutropenia: Observed in 31% of patients.
"These results represent a significant advancement for patients with limited chemotherapy options."
Efficacy Signal Across Tumor Types
Tumor responses were observed across several tumor types, including lung cancer, melanoma, and neuroendocrine tumors. Notably, among head and neck cancer patients treated at the optimal dose, 4 of 14 experienced significant tumor shrinkage, with 3 of those responses ongoing at the time of analysis. The median duration of response was 8.8 months.
Expert Commentary
Prof. Martin Wermke, study lead, stated that IMA401 enables the targeting of intracellular tumor markers and noted plans to test the therapy in combination with another TCER targeting a different tumor marker in lung cancer.
Prof. Martin Bornhäuser, managing director of NCT/UCC Dresden, commented on the ECTU's role in providing early access to new therapies for patients.
Prof. Uwe Platzbecker, Medical Director of University Hospital Dresden, expressed support for expanding the ECTU to bring more innovative treatments to patients.
Prof. Esther Troost, Dean of the Faculty of Medicine at TUD, highlighted the international significance of the study.
Publication and Next Steps
The full results will be presented at the ASCO Annual Meeting on May 31, 2026, and published simultaneously in Nature Medicine.
ClinicalTrials.gov Identifier: NCT05359445