Experimental cancer combo shows early promise but study halted

NCT ID NCT04234113

Terminated Disease control Sponsor: SOTIO Biotech AG Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tested a new drug called nanrilkefusp alfa, which helps activate immune cells, both alone and combined with the immunotherapy pembrolizumab. It included 115 people with various advanced solid tumors that had stopped responding to standard treatments. The study was terminated early, but researchers collected important safety and dosing information.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Nanrilkefusp alfa (a lab-made protein that boosts immune cells) and pembrolizumab (an immunotherapy drug)
What this could lead to: If successful, this could point toward a new combination treatment for several hard-to-treat cancers by helping the immune system attack tumors more effectively.
What could go wrong: This was an early, small phase 1 trial that was terminated, so results are limited. The treatment may cause serious side effects like immune overactivation, and it is unclear if it will work in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

anal carcinoma anus neoplasm biliary tract cancer Biliary Tract Neoplasms cervical cancer cutaneous neuroendocrine carcinoma gastric cancer gastric neoplasm head and neck squamous cell carcinoma hepatocellular carcinoma melanoma mesothelioma non-small cell lung carcinoma ovarian cancer renal cell carcinoma skin squamous cell carcinoma small cell lung carcinoma Squamous Cell Carcinoma of Head and Neck thymus cancer Thymus Neoplasms thyroid cancer Thyroid Neoplasms triple-negative breast carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms Uterine Cervical Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANAL CANCER BILIARY TRACT CANCER BLADDER CANCER CERVICAL CANCER GASTRIC CANCER HEAD AND NECK SQUAMOUS CELL CARCINOMA HEPATOCELLULAR CARCINOMA MELANOMA MERKEL CELL CARCINOMA MESOTHELIOMA MICROSATELLITE INSTABILITY HIGH NON-SMALL CELL LUNG CANCER OVARIAN CANCER RENAL CELL CARCINOMA SKIN SQUAMOUS CELL CARCINOMA SMALL CELL LUNG CANCER THYMIC CANCER THYROID CANCER TRIPLE NEGATIVE BREAST CANCER

Contacts and locations

Locations

Centre Léon Bérard

Lyon, France, 69379, France
Hopital Saint Louis

Paris, 75010, France
Hôpitaux Universitaires de Marseille Timone

Marseille, 13005, France
Institut Claudius Regaud

Toulouse, France, 31059, France
Institut Gustave Roussy

Paris, France, 94805, France
Institut de Cancerologie de L'Ouest

Saint-Herblain, 44805, France
MD Anderson Cancer Center

Houston, Texas, 77030, United States
Masarykův Onkologický Ústav Brno Klinika komplexní onkologické péče

Brno, Czechia, 65653, Czechia
University Hospital Sanchinarro

Madrid, 28050, Spain
University of Pittsburgh

Pittsburgh, Pennsylvania, 15216, United States
Vall d'Hebron Institute of Oncology

Barcelona, Spain, 08035, Spain
Yale Cancer Center

New Haven, Connecticut, 06520, United States

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