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Cancer drug trial halted midway: what happened?

NCT ID NCT04504916

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called VLS-101 in 102 people with advanced solid tumors, including breast, lung, ovarian, stomach, and pancreatic cancers that had stopped responding to standard treatments. The goal was to see if the drug could shrink tumors. However, the trial was terminated early, so results are limited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

102 people

The number who actually took part.

Started

Oct 2020

Finished

Jun 2023

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: * Has a confirmed diagnosis of solid tumor for one of the following types of cancer: previously treated cancers of triple-negative breast cancer (TNBC), non-TNBC HER2-negative breast cancer, non-squamous non-small-cell lung cancer (NSCLC), gastric cancer, pancreatic cancer, or platinum-resistant ovarian cancer. * Has metastatic disease that has progressed during or following previous treatment appropriate for the disease type * Presence of radiographically measurable disease. * Is willing to provide tumor tissue * Has adequate organ function * Has a negative test or adequate therapy for human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C. * Has completed all prior therapy. * Female subjects of childbearing potential must have a negative serum pregnancy test. * Both male and female subjects must be willing to use adequate contraception. Exclusion Criteria: * Has peripheral neuropathy of Grade \>1. * Has a malignancy involving the central nervous system. * Has another major cancer. * Has an uncontrolled ongoing infection. * Has significant cardiovascular disease. * Has a known diagnosis of liver cirrhosis. * Is pregnant or breastfeeding. * Has had major surgery within 4 weeks before the start of study therapy. * Has known tumor resistance or intolerance to a prior MMAE-containing drug. * Is concurrently participating in another therapeutic or imaging clinical trial.

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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

  • AdventHealth Orlando ( Site 0003)

    Orlando, Florida, 32804, United States

  • BC Cancer Vancouver ( Site 0011)

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

    Québec, Quebec, G1J 1Z4, Canada

  • Centre intégré de cancérologie du CHUM ( Site 0016)

    Montreal, Quebec, H2X 0A9, Canada

  • Cross Cancer Institute ( Site 0012)

    Edmonton, Alberta, T6G 1Z2, Canada

  • Jewish General Hospital ( Site 0013)

    Montreal, Quebec, H3T 1E2, Canada

  • John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0002)

    Hackensack, New Jersey, 07601, United States

  • MD Anderson ( Site 0001)

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital ( Site 0017)

    Boston, Massachusetts, 02114, United States

  • Memorial Regional Hospital-Memorial Cancer Institute ( Site 0005)

    Hollywood, Florida, 33021, United States

  • Memorial Sloan Kettering Cancer Center ( Site 0007)

    New York, New York, 10021, United States

  • Princess Margaret Cancer Centre ( Site 0006)

    Toronto, Ontario, M5G 2M9, Canada

  • Swedish Medical Center ( Site 0008)

    Seattle, Washington, 98104, United States

  • The University of Texas Health Science Center at San Antonio ( Site 0004)

    San Antonio, Texas, 78229, United States

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