New combo aims to reboot immunotherapy in resistant cancers

NCT ID NCT04219254

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests a new drug called BI-1206, given alongside the immunotherapy pembrolizumab, in adults with advanced solid tumors that have stopped responding to prior anti-PD-1/PD-L1 treatment. The study aims to find the safest dose and check for early signs of tumor shrinkage. About 197 participants will receive the combination intravenously or under the skin every three weeks.

What this could mean

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

Active substance
BI-1206 (a monoclonal antibody) combined with pembrolizumab
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors who have stopped responding to standard immunotherapy.
What could go wrong
This is an early-phase trial (phase 1/2a) with a small number of participants. The drug may not work or could cause serious side effects. It is not yet proven to be safe or effective.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Centrul de Oncologie SF Nectarie SRL

    TERMINATED

    Craiova, Romania

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Spain

  • HealthPartners Institute - Regions Cancer Care Center,

    COMPLETED

    Saint Paul, Minnesota, 55101, United States

  • Hm Ciocc Málaga

    NOT_YET_RECRUITING

    Málaga, Spain

  • Hospital Puerta de Hierro

    RECRUITING

    Majadahonda, Spain

  • Hospital Universitari Dexeus

    RECRUITING

    Barcelona, Spain

  • Hospital Universitari Vall D´Hebron

    RECRUITING

    Barcelona, Spain

  • Hospital Virgen de la Macarena

    RECRUITING

    Seville, Spain

  • Institut Català d'Oncologia Hospital Duran i Reynals

    RECRUITING

    Barcelona, Spain

  • Institutul Oncologic "Prof. Dr. Ion Chiricuta"

    RECRUITING

    Cluj-Napoca, Romania

  • Instytut Centrum Zdrowia Matki Polki

    TERMINATED

    Lodz, Poland

  • Israel-Georgian Medical Research Clinic Helsicore

    TERMINATED

    Tbilisi, Georgia

  • Jerarsi Clinic

    RECRUITING

    Tbilisi, Georgia

  • Karolinska University Hospital, Solna

    RECRUITING

    Stockholm, Sweden

  • LTD High Technology Hospital Med Center

    RECRUITING

    Batumi, Georgia

  • Lund University Hospital

    RECRUITING

    Lund, Sweden

  • Maria Skłodowska-Curie National Institute of Oncology

    TERMINATED

    Gliwice, Poland

  • Medical University of Silesia

    RECRUITING

    Katowice, Poland

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Germany

  • NEXT Oncology

    COMPLETED

    San Antonio, Texas, 78229, United States

  • Nationales Centrum für Tumorerkrankungen

    RECRUITING

    Heidelberg, Germany

  • Oklahoma University , Stephenson Cancer Center

    COMPLETED

    Oklahoma City, Oklahoma, 73104, United States

  • Sahlgrenska University Hospital

    COMPLETED

    Gothenburg, Sweden

  • Sarah Cannon Research Institute

    COMPLETED

    Denver, Colorado, 80218, United States

  • University of California Los Angeles

    RECRUITING

    Los Angeles, California, 90024, United States

  • Universität des Saarlandes

    RECRUITING

    Homburg, Germany

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