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

NCT03425279 | Completed Phase 1 FDA Drug

• 1 other identifier: BA3011-001
• Study Type: interventional
• Target: 245
• Locations: 3 countries
• Sites: 40

Brief Summary

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

Conditions

Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma

Keywords

late stage; stage 3; stage 4; cancer; undifferentiated pleomorphic sarcoma; myxofibrosarcoma

Outcome Measures

Primary Outcomes (4)

• Phase 1: Safety Profile

  Assess dose limiting toxicity as defined in the protocol

  Up to 24 months

• Phase 1: Safety Profile

  Assess maximum tolerated dose as defined in the protocol

  Up to 24 months

• Phase 1 and 2: Safety Profile

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

  Up to 24 months

• 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

  Up to 24 months

Secondary Outcomes (12)

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Overall response rate (ORR)

  Up to 24 months

• Phase 1: Immunogenicity

  Up to 24 months

Study Arms (2)

BA3011

EXPERIMENTAL

Phase 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.

Biological: CAB-AXL-ADC

Combination Therapy

EXPERIMENTAL

Phase 2: BA3011 in combination with PD-1 inhibitor.

Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

Interventions

CAB-AXL-ADC BIOLOGICAL

Conditionally active biologic anti-AXL antibody drug conjugate

BA3011; Combination Therapy

PD-1 inhibitor BIOLOGICAL

PD-1 inhibitor

Combination Therapy

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioAtla, Inc.: lead

Study Sites (40)

The University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

USC Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Tower Hematology Oncology Medical Group

Los Angeles, California, 90048, United States

Location

Precision NextGen Oncology

Los Angeles, California, 90212, United States

Location

UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)

San Francisco, California, 94158, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Sarah Cannon Research Institute at Health One

Denver, Colorado, 80218, United States

Location

Children's Research Institute

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

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Comprehensive Cancer Center of Nevada

Las Vegas, Nevada, 89169, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Memorial Sloan Kettering

New York, New York, 10065, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University Hospitals Seidman Cancer Center

Cleveland, Ohio, 44106, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Abramson Cancer Center at Pennsylvania Hospital

Philadelphia, Pennsylvania, 19106, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Histiocytoma, Malignant Fibrous; Dermatofibrosarcoma; Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Histiocytoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Sarcoma; Fibrosarcoma

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: February 7, 2018
• Study Start: February 15, 2018
• Primary Completion: January 8, 2025
• Study Completion: January 8, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (35); HK (2); TW (3)