Experimental HER2 drug trial halted early – what it means

NCT ID NCT05013554

Terminated Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage trial tested an experimental drug called SAR443216 in 44 adults with advanced HER2-expressing solid tumors (such as breast, lung, or gastric cancer) that had come back or stopped responding to standard treatments. The study aimed to find a safe dose and check for early signs of tumor shrinkage. However, the trial was terminated, so full results are not available.

What this could mean

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

Active substance: SAR443216 (an experimental drug given by IV or injection)
What this could lead to: If successful, this could point toward a new treatment option for people with HER2-expressing solid tumors that have stopped responding to other therapies.
What could go wrong: This was a very early (Phase 1) trial that was terminated, so results are limited. The drug may not prove effective or safe 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.

breast cancer breast neoplasm cancer gastric cancer gastric neoplasm lung cancer lung neoplasm neoplasm

As listed by the trial registrant

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

BREAST CANCER GASTRIC CANCER LUNG NEOPLASM MALIGNANT NEOPLASM NEOPLASM MALIGNANT

Contacts and locations

Locations

Investigational Site Number : 0560002

Ghent, 9000, Belgium
Investigational Site Number : 1580001

Taichung, 404, Taiwan
Investigational Site Number : 1580002

Tainan, 704, Taiwan
Investigational Site Number : 2500001

Pierre-Bénite, 69495, France
Investigational Site Number : 2500002

Villejuif, 94800, France
Investigational Site Number : 4100001

Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100002

Seoul, Seoul-teukbyeolsi, 05505, South Korea
Investigational Site Number : 7240001

Madrid, Madrid, Comunidad de, 28040, Spain
Investigational Site Number : 7240002

Madrid / Madrid, Madrid, Comunidad de, 28050, Spain
Investigational Site Number : 7240003

Barcelona, Barcelona [Barcelona], 08035, Spain
~University of Texas - MD Anderson Cancer Center Site Number : 8400002

Houston, Texas, 77030, United States

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