Experimental cancer combo trial halted early – what it means for patients

NCT ID NCT04278144

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tested a new drug called BDC-1001, alone or with the immunotherapy nivolumab, in 175 people with advanced HER2-positive cancers (like breast, colorectal, and stomach cancers) that had stopped responding to other treatments. The study aimed to check safety and find the right dose, but it was terminated early, so full results are not available. The approach tries to stimulate the immune system to attack cancer cells, but it is still experimental.

What this could mean

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

Active substance

BDC-1001 (an immune-stimulating antibody conjugate) and nivolumab (Opdivo, an immunotherapy)

What this could lead to

If successful, this could point toward a new treatment option for advanced HER2-positive cancers that have stopped responding to standard therapies.

What could go wrong

This was a very early (Phase 1/2) trial that was terminated, so results are limited. The combination may cause significant immune-related side effects, and it is unclear if it will work better than existing treatments.

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.

Biliary Tract Neoplasms breast neoplasm colorectal cancer colorectal carcinoma colorectal neoplasm digestive system neoplasm endometrial carcinoma endometrium neoplasm gastric neoplasm gastroesophageal cancer Head and Neck Neoplasms HER2 positive breast carcinoma non-small cell lung carcinoma

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asan Medical Center

    Seoul, Songpa-gu, 05505, South Korea

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007, United States

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, 28034, Spain

  • Hospital Universitario Vall d'Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital del Mar

    Barcelona, Catalonia, 08003, Spain

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204, United States

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10065, United States

  • START Midwest

    Grand Rapids, Michigan, 49546, United States

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • South Texas Accelerated Research Therapeutics

    San Antonio, Texas, 78229, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States