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Experimental drug combo targets Hard-to-Treat sarcomas

NCT ID NCT03425279

Disease control Sponsor: BioAtla, Inc. 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 study tested a new drug called mecbotamab vedotin, alone or with the immunotherapy nivolumab, in 245 adults and teens aged 12+ with advanced solid tumors, including sarcomas. The goal was to check safety and see if the drug shrinks tumors. The trial is now complete, and results will help decide if further testing is needed.

What this could mean

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

Active substance
mecbotamab vedotin (a targeted drug) and nivolumab (an immunotherapy)
What this could lead to
If successful, this could provide a new treatment option for people with advanced sarcomas that are hard to treat.
What could go wrong
This is an early-phase trial (Phase 1/2), so the drug may not work or could have serious side effects. Results are not yet confirmed for broader use.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

245 people

The number who actually took part.

Started

Feb 2018

Finished

Jan 2025

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

12 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: * Patients must have measurable disease. * Age ≥ 12 years (Phase 2) * Adequate renal function * Adequate liver function * Adequate hematological function * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of at least three months. Exclusion Criteria: * Patients must not have clinically significant cardiac disease. * Patients must not have known non-controlled CNS metastasis. * Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study. * Patients must not have had major surgery within 4 weeks before first BA3011 administration. * Patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. * Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C. * Patients must not be women who are pregnant or breast feeding.

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Conditions

The condition(s) this trial relates to.

dermatofibrosarcoma protuberans myxofibrosarcoma neoplasm undifferentiated pleomorphic sarcoma

As listed by the trial registrant

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

Myxofibrosarcoma Undifferentiated pleomorphic sarcoma

Contacts and locations

Locations

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106, United States

  • Chang Gung Memorial Hospital

    Taoyuan, Taiwan

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010, United States

  • Columbia University

    New York, New York, 10032, United States

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Norton Cancer Institute

    Louisville, Kentucky, 40202, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Precision NextGen Oncology

    Los Angeles, California, 90212, United States

  • Prince of Wales Hospital

    Hong Kong, Hong Kong

  • Queen Mary Hospital

    Hong Kong, Hong Kong

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263, United States

  • Sarah Cannon Research Institute at Health One

    Denver, Colorado, 80218, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Tennessee Oncology

    Nashville, Tennessee, 37203, United States

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724, United States

  • Tower Hematology Oncology Medical Group

    Los Angeles, California, 90048, United States

  • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)

    San Francisco, California, 94158, United States

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033, United States

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.