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CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504488
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : September 13, 2021
Sponsor:
Information provided by (Responsible Party):
BioAtla, Inc.

Brief Summary:
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Triple Negative Breast Cancer Melanoma Head and Neck Cancer Biological: CAB-ROR2-ADC Biological: PD-1 inhibitor Phase 1 Phase 2

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 BA3021, a conditionally active biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2-ADC) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : June 30, 2023


Arm Intervention/treatment
Experimental: Monotherapy - CAB-ROR2-ADC (BA3021) alone
BA3021 alone
Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Name: BA3021

Experimental: Combination Therapy
CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Name: BA3021

Biological: PD-1 inhibitor
PD-1 inhibitor




Primary Outcome Measures :
  1. Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess dose limiting toxicity as defined in the protocol

  2. Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess maximum tolerated dose as defined in the protocol

  3. Phase 1 and 2: Safety Profile [ Time Frame: Up to 24 months ]
    Frequency and severity of AEs and/or SAEs

  4. Phase 2: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
    Proportion of patients who achieve a confirmed CR or PR


Secondary Outcome Measures :
  1. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Plasma concentrations of ADC, total antibody and MMAE

  2. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Peak Plasma Concentration (Cmax)

  3. Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Area under the plasma concentration versus time curve

  4. Phase 1: Confirmed Objective Response Rate (ORR) [ Time Frame: Up to 24 months ]
    Proportion of patients who achieve a confirmed CR or PR

  5. Phase 1: Immunogenicity [ Time Frame: Up to 24 months ]
    The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)

  6. 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

  7. 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

  8. Phase 1 and 2: Best overall response (OR) [ Time Frame: Up to 24 months ]
    All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

  9. 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

  10. 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

  11. Phase 1 and 2: Overall survival (OS) [ Time Frame: Up to 24 months ]
    Time from the first dose of BA3021 treatment until death due to any cause

  12. Phase 1 and 2: Tumor size [ Time Frame: Up to 24 months ]
    Percent change from baseline in tumor size



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (SoC) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy.
  • Patients must have measurable disease.
  • For the dose expansion phase: Patients with locally advanced unresectable or metastatic, non-small cell lung cancer (NSCLC), triple negative breast cancer (TNBC) and soft tissue sarcoma (STS)
  • Age ≥ 18 years.
  • 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 wellas 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 BA3021 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504488


Contacts
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Contact: Hazel Buncab 858-263-1598 ext 8582631598 hbuncab@bioatla.com
Contact: Ji Hwan Lee 858-286-7702 jlee@bioatla.com

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Pavani Chalasani, MD    520-626-0191    pavanic@email.arizona.edu   
Principal Investigator: Pavani Chalasani, MD         
United States, California
Cedar-Sinai Recruiting
Los Angeles, California, United States, 90211
Contact: Roland Menendez    310-231-2184    rmenendez@theangelesclinic.org   
Contact: Linda Ford, PA-C    310-285-7268    Linda.ford@cshs.org   
Principal Investigator: Omid Hamid, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Teresa Medina, MD    303-266-3764    theresa.medina@ucdenver.edu   
Contact: Rebeca Elizondo    720-848-4288    rebeca.elizondo@cuanschutz.edu   
Principal Investigator: Teresa Medina, MD         
Sarah Cannon Research Institute at Health One Recruiting
Denver, Colorado, United States, 80218
Contact: Gerald Falchook, MD    720-754-2610    gerald.falchook@scresaerch.net   
Contact: Susan Hall    720-754-2610    Susan.Hall3@sarahcannon.com   
Principal Investigator: Gerald Falchook, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Samantha Wheeler    646-888-1385    wheelers@mskcc.org   
Contact: Bella Pinque    646-888-1394    PinqueI@mskcc.org   
Principal Investigator: Bill Tap         
Principal Investigator: Paul Chapman         
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jacqueline Andrews    813-745-3553    Jacqueline.Andrews@moffitt.org   
Principal Investigator: Mihaela Druta, MD         
Principal Investigator: Andres Saltos, MD         
United States, Nevada
Comprehensive Cancer Care of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
Contact: Fadi Braiteh, MD    702-952-3400    Fadi.Braiteh@usoncology.com   
Principal Investigator: Fadi Braiteh, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Swathi Balaji    212-304-5548    sb4461@cumc.columbia.edu   
Contact: Morgan Bryant    212-342-9004    mb4695@cumc.columbia.edu   
Principal Investigator: Matthew Ingham, MD         
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Jeffrey Kettler    336-716-4760    jkettler@wakehealth.edu   
Contact: Nikolas Soetermans    336-713-5865    nsoeterm@wakehealth.edu   
Principal Investigator: Lowell Hart, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Kyaw Thein, MD       theink@ohsu.edu   
Contact: Andrzej Stadnik    503-494-2636    stadnik@ohsu.edu   
Principal Investigator: Kyaw Thein, MD         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard Burris, MD       Howard.Burris@SarahCannon.com   
Contact: Leigh Bumpous    615-748-0767    Leigh.Bumpous@SarahCannon.com   
Principal Investigator: Howard Burris, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Yoko Yamamura    713-792-9869    yyamamur@mdanderson.org   
Principal Investigator: Siqing Fu, MD         
United States, Utah
University of Utah - Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Mia Klonsky    801-581-5260    Mia.Klonsky@hci.utah.edu   
Contact: Ashley Lewary       Ashley.Leary@hci.utah.edu   
Principal Investigator: Joanne Jeter, MD         
Sponsors and Collaborators
BioAtla, Inc.
Investigators
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Study Director: Philippe Martin BioAtla, Inc.
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Responsible Party: BioAtla, Inc.
ClinicalTrials.gov Identifier: NCT03504488    
Other Study ID Numbers: BA3021-001
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Head and Neck Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Breast Neoplasms
Breast Diseases
Skin Diseases
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents