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CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT03504488
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
BioAtla, LLC

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
Solid Tumor Non Small Cell Lung Cancer Triple Negative Breast Cancer Soft Tissue Sarcoma Biological: CAB-ROR2-ADC 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) in patients with advanced solid tumors. This study will consist of a dose escalation phase and a dose expansion phase.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : May 13, 2020
Estimated Study Completion Date : May 13, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BA3021
All patients will receive BA3021, CAB-ROR2-ADC.
Biological: CAB-ROR2-ADC
Conditionally active biologic anti-ROR2 antibody drug conjugate
Other Name: BA3021




Primary Outcome Measures :
  1. Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3021) [ Time Frame: Up to 24 months ]
    Measured by frequency and severity of adverse events

  2. Dose Limiting Toxicities (DLTs) [ Time Frame: DLT will be assessed from first treatment cycle (3 weeks) ]
    Number of DLTs

  3. Maximum Tolerated Dose (MTD) [ Time Frame: MTD will be assessed from first treatment cycle (3 weeks) ]
    Number of DLTs

  4. Anti-tumor activity [ Time Frame: Up to 24 months ]
    Overall Response Rate (ORR) according to RECIST version 1.1


Secondary Outcome Measures :
  1. Pharmacokinetics; Cmax [ Time Frame: Up to 24 months ]
    Maximum observed concentration of BA3021

  2. Pharmacokinetics; AUC [ Time Frame: Up to 24 months ]
    Area under the concentration versus time curve of BA3021

  3. Immunogenicity of BA3021 [ Time Frame: Up to 24 months ]
    Presence of anti-drug antibodies (ADA)



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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 received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to 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 Grade 2 or higher peripheral neuropathy.
  • 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
Contact: Vanessa Esquibel 858-263-1598 vesquibel@bioatla.com
Contact: Yong Ben 858-558-0708 ext 3125 yben@bioatla.com

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Tate Closson-Niese    720-848-0669    Tate.closson-Niese@ucdenver.edu   
Principal Investigator: Anthony Elias, MD, PhD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Zach Godwin    503-418-9324    godwinz@ohsu.edu   
Principal Investigator: Matthew Taylor, MD         
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Howard Burris, MD       Howard.Burris@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         
Sponsors and Collaborators
BioAtla, LLC
Investigators
Study Director: Yong Ben BioAtla, LLC

Responsible Party: BioAtla, LLC
ClinicalTrials.gov Identifier: NCT03504488     History of Changes
Other Study ID Numbers: BA3021-001
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Sarcoma
Triple Negative Breast Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Breast Neoplasms
Breast Diseases
Skin Diseases