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

April 17, 2024 updated by: BioAtla, Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
        • Principal Investigator:
          • Thomas Yau, MD
      • Hong Kong, Hong Kong
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Herbert Loong, MD
  • Taiwan
      • Tainan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Principal Investigator:
          • Yu-Min Yeh, MD
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Chueh-Chuan Yen, MD
      • Taoyuan, Taiwan
        • Recruiting
        • Chang Gung Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Wen-Cheng Chang, MD
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • The University of Arizona Cancer Center
        • Contact:
        • Principal Investigator:
          • Abhijeet Kumar, MD
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Jacob Thomas, MD
      • Los Angeles, California, United States, 90027
        • Completed
        • Children's Hospital Los Angeles
      • Los Angeles, California, United States, 90048
        • Completed
        • Tower Hematology Oncology Medical Group
      • Los Angeles, California, United States, 90212
      • San Francisco, California, United States, 94158
        • Recruiting
        • UCSF Medical Center - Cancer Immunotherapy Clinic (CIC)
        • Principal Investigator:
          • Brian Schulte, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Sarah Cannon Research Institute at Health One
        • Contact:
        • Principal Investigator:
          • Gerald Falchook, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's Research Institute
        • Contact:
        • Principal Investigator:
          • AeRang Kim, MD, PhD
    • Florida
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Cancer Institute
        • Contact:
        • Principal Investigator:
          • Jaspreet Grewal, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
        • Principal Investigator:
          • Gregory Cote
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Glenn Hanna, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine - Siteman Cancer Center
        • Principal Investigator:
          • Mia Weiss, MD
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Completed
        • Comprehensive Cancer Center of Nevada
    • New York
      • Buffalo, New York, United States, 14263
        • Recruiting
        • Roswell Park Cancer Institute
        • Principal Investigator:
          • Ajay Gupta
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bill M. Tap, MD
      • New York, New York, United States, 10032
        • Active, not recruiting
        • Columbia University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Completed
        • Duke Cancer Institute
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Baptist Health
        • Contact:
        • Principal Investigator:
          • Paul Savage, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Christ Hospital
        • Contact:
        • Principal Investigator:
          • Alexander N. Starodub, MD, PhD
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • University Hospitals Seidman Cancer Center
        • Contact:
        • Principal Investigator:
          • Ankit Mangla, MD
      • Columbus, Ohio, United States, 43205
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
        • Principal Investigator:
          • Gabriel Tinoco, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lara Davis, MD
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19106
      • Philadelphia, Pennsylvania, United States, 19104
        • Completed
        • The Children's Hospital of Philadelphia
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Oncology
        • Principal Investigator:
          • David Spigel, MD
        • Contact:
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt Ingram Cancer Center
        • Contact:
        • Principal Investigator:
          • Elizabeth Davis, MD
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Mary Crowley Cancer Research
        • Contact:
        • Principal Investigator:
          • James Strauss, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jordi Rodon, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah - Huntsman Cancer Institute
        • Contact:
        • Principal Investigator:
          • Anna Chalmers, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance
        • Principal Investigator:
          • Elizabeth Loggers, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital and the Medical College of Wisconsin
        • Principal Investigator:
          • John Charlson, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Combination Therapy
Phase 2: BA3011 in combination with PD-1 inhibitor.
Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Biological: PD-1 inhibitor
PD-1 inhibitor
Experimental: BA3011

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
Conditionally active biologic anti-AXL antibody drug conjugate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Safety Profile
Time Frame: Up to 24 months
Assess dose limiting toxicity as defined in the protocol
Up to 24 months
Phase 1: Safety Profile
Time Frame: Up to 24 months
Assess maximum tolerated dose as defined in the protocol
Up to 24 months
Phase 2: Confirmed overall response rate (ORR) per RECIST v1.1
Time Frame: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Up to 24 months
Phase 1 and 2: Safety Profile
Time Frame: Up to 24 months
Frequency and severity of AEs and/or SAEs, and changes from baseline in laboratory parameters and vital signs
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Plasma concentrations of ADC, total antibody and MMAE
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Peak Plasma Concentration (Cmax)
Up to 24 months
Phase 1: Pharmacokinetics
Time Frame: Up to 24 months
Area under the plasma concentration versus time curve (AUC)
Up to 24 months
Phase 1: Overall response rate (ORR)
Time Frame: Up to 24 months
Proportion of patients who achieve a confirmed CR or PR
Up to 24 months
Phase 1: Immunogenicity
Time Frame: Up to 24 months
The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Up to 24 months
Phase 1 and 2: Duration of response (DOR)
Time Frame: Up to 24 months
Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Up to 24 months
Phase 1 and 2: Progression-free survival (PFS)
Time Frame: Up to 24 months
Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
Up to 24 months
Phase 1 and 2: Disease control rate (DCR)
Time Frame: Up to 24 months
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Up to 24 months
Phase 1 and 2: Time to response (TTR)
Time Frame: Up to 24 months
Time from the first dose of investigational product until the first documentation of OR
Up to 24 months
Phase 1 and 2: Overall survival (OS)
Time Frame: Up to 24 months
Time from the first dose of BA3011 treatment until death due to any cause
Up to 24 months
Phase 1 and 2: Tumor size
Time Frame: Up to 24 months
Percent change from baseline in tumor size
Up to 24 months
Phase 1 and 2: Best overall response (BOR)
Time Frame: Up to 24 months
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioAtla, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 7, 2018

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BA3011-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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