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Undifferentiated Pleomorphic SarcomaPhase 1/2NCT03425279

CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

A Phase 1/2 study testing CAB-AXL-ADC and PD-1 inhibitor in people with Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, run by BioAtla, Inc. at 40 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors. Read more about this study

Who is it for?
Ages 12 years and older
What is being tested?
CAB-AXL-ADC and PD-1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
245 participants
Where
40 sitesin 3 countries
Study dates
15 Feb 2018to 8 Jan 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

40 sites in 3 countries.

40 sites in 3 countries

United States35 sites

  • University of Colorado

    Aurora, Colorado, 80045

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Northwestern University

    Chicago, Illinois, 60611

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University Hospitals Seidman Cancer Center

    Cleveland, Ohio, 44106

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • Sarah Cannon Research Institute at Health One

    Denver, Colorado, 80218

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • USC Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Tower Hematology Oncology Medical Group

    Los Angeles, California, 90048

  • Precision NextGen Oncology

    Los Angeles, California, 90212

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Vanderbilt Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Columbia University

    New York, New York, 10032

  • Memorial Sloan Kettering

    New York, New York, 10065

  • The Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • Abramson Cancer Center at Pennsylvania Hospital

    Philadelphia, Pennsylvania, 19106

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)

    San Francisco, California, 94158

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Washington University School of Medicine - Siteman Cancer Center

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

  • Children's Research Institute

    Washington D.C., District of Columbia, 20010

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan

Other trials in Taiwan

Hong Kong2 sites

  • Prince of Wales Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Phase 1/2 Dose Escalation and Dose Expansion Study of Mecbotamab Vedotin (BA3011) Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors

The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.

Read the detailed description

This is a multi-center, open-label, Phase 1/2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of mecbotamab vedotin (BA3011), a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC) in patients with advanced solid tumors.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (enrollment complete as of Jan 2024).

Phase 2 will consist of two parts. Part 1 is designed to evaluate mecbotamab vedotin alone and with nivolumab in patients with various types of advanced sarcomas (enrollment complete as of Jan 2024). Part 2 will evaluate the safety and efficacy of mecbotamab vedotin in patients with undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS).

Being tested
CAB-AXL-ADC, PD-1 inhibitor
Keywords
late stage, stage 3, stage 4, cancer, undifferentiated pleomorphic sarcoma, myxofibrosarcoma
Medical subject headings
Histiocytoma, Malignant Fibrous, Dermatofibrosarcoma, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CAB-AXL-ADCBiological

    Conditionally active biologic anti-AXL antibody drug conjugate

  • PD-1 inhibitorBiological

    PD-1 inhibitor

Study groups in NCT03425279
Study groupRoleWhat they receive
BA3011ExperimentalPhase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with PD-1 inhibitor.
Receives: Biological: CAB-AXL-ADC
Combination TherapyExperimentalPhase 2: BA3011 in combination with PD-1 inhibitor.
Receives: Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Safety Profile

    Assess dose limiting toxicity as defined in the protocol

    Measured: Up to 24 months

  2. Phase 1: Safety Profile

    Assess maximum tolerated dose as defined in the protocol

    Measured: Up to 24 months

  3. Phase 1 and 2: Safety Profile

    Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs

    Measured: Up to 24 months

  4. Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1

    Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

    Measured: Up to 24 months

Secondary outcomes (12)

  1. Phase 1: Pharmacokinetics

    Plasma concentrations of ADC, total antibody and MMAE

    Measured: Up to 24 months

  2. Phase 1: Pharmacokinetics

    Peak Plasma Concentration (Cmax)

    Measured: Up to 24 months

  3. Phase 1: Pharmacokinetics

    Area under the plasma concentration versus time curve (AUC)

    Measured: Up to 24 months

  4. Phase 1: Overall response rate (ORR)

    Proportion of patients who achieve a confirmed CR or PR

    Measured: Up to 24 months

  5. Phase 1: Immunogenicity

    The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

    Measured: Up to 24 months

  6. Phase 1 and 2: Duration of response (DOR)

    Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first

    Measured: Up to 24 months

  7. Phase 1 and 2: Progression-free survival (PFS)

    Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first

    Measured: Up to 24 months

  8. Phase 1 and 2: Best overall response (BOR)

    All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

    Measured: Up to 24 months

  9. Phase 1 and 2: Disease control rate (DCR)

    Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks

    Measured: Up to 24 months

  10. Phase 1 and 2: Time to response (TTR)

    Time from the first dose of investigational product until the first documentation of OR

    Measured: Up to 24 months

  11. Phase 1 and 2: Overall survival (OS)

    Time from the first dose of BA3011 treatment until death due to any cause

    Measured: Up to 24 months

  12. Phase 1 and 2: Tumor size

    Percent change from baseline in tumor size

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2018
  2. Study start15 Feb 2018
  3. Primary completion8 Jan 2025
  4. Study completion8 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
245 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03425279
Sponsor's protocol ID
BA3011-001
Status last verified
Sep 2025
First submitted
22 Jan 2018
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hoff CO, Dal Lago EA, Siqueira JM, de Sousa LG, El-Naggar AK, Ahnert JR, Ferrarotto R. First Use of AXL Targeting in Metastatic, Refractory, Adenoid Cystic Carcinoma: A Case Report. JCO Precis Oncol. 2024 Apr;8:e2300633. doi: 10.1200/PO.23.00633.

    PubMed 38579194

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAB-AXL-ADC and PD-1 inhibitor in people with Undifferentiated Pleomorphic Sarcoma and Myxofibrosarcoma, run by BioAtla, Inc. at 40 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in United States, Taiwan, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Safety Profile (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03425279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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