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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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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