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Experimental HER2 drug trial halted early – what it means

NCT ID NCT05013554

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

44 people

The number who actually took part.

Started

Aug 2021

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants must be ≥ 18 years of age * Histologically or cytologically confirmed diagnosis of metastatic solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * All participants should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion. * Body weight within \[45 - 150 kg\] (inclusive) * All Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Capable of giving signed informed consent Exclusion Criteria: * Any clinically significant cardiac disease * History of or current interstitial lung disease or pneumonitis * Uncontrolled or unresolved acute renal failure * Prior solid organ or hematologic transplant. * Known positivity with human immunodeficiency virus (HIV), known active hepatitis A, B, and C, or uncontrolled chronic or ongoing infectious requiring parenteral treatment. * Receipt of a live-virus vaccination within 28 days of planned treatment start * Participation in a concurrent clinical study in the treatment period. * Inadequate hematologic, hepatic and renal function * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions. The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

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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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