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

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ClinicalTrials.gov Identifier: NCT03425279
Recruitment Status : Recruiting
First Posted : February 7, 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-AXL-ADC in solid tumors

Condition or disease Intervention/treatment Phase
Solid Tumor Non Small Cell Lung Cancer Castration-resistant Prostate Cancer Pancreatic Cancer Biological: CAB-AXL-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 BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-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 BA3011 in Patients With Advanced Solid Tumors
Actual Study Start Date : February 15, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BA3011
All patients will receive BA3011, CAB-AXL-ADC.
Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate




Primary Outcome Measures :
  1. Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3011) [ 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: [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 BA3011

  2. Pharmacokinetics: AUC [ Time Frame: Up to 24 months ]
    Area under the concentration versus time curve of BA3011

  3. Immunogenicity of BA3011 [ 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:

  • For the dose escalation phase: Patients with histologically or cytologically confirmed locally advanced or metastatic solid tumor and have failed 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), castration-resistant prostate cancer (CRPC) and pancreatic ductal adenocarcinoma (PDAC)
  • 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 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 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): NCT03425279


Contacts
Contact: Yong Ben, MD 858-558-0708 ext 3125 yben@bioatla.com
Contact: Vanessa Esquibel 858-263-1598 vesquibel@bioatla.com

Locations
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Olivia Pearson    720-848-9382    Olivia.Pearson@ucdenver.edu   
Principal Investigator: Robert Doebele, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Sohad Riad       soha.riad@moffitt.org   
Principal Investigator: Jingsong Zhang, MD         
United States, New York
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
Contact: Kelsey Ricci    646-888-4303    riccik@mskcc.org   
Principal Investigator: Eileen M. O'Reilly, MD         
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
Principal Investigator: Jordi Rondon, MD         
Sponsors and Collaborators
BioAtla, LLC
Investigators
Study Director: Yong Ben BioAtla, LLC

Responsible Party: BioAtla, LLC
ClinicalTrials.gov Identifier: NCT03425279     History of Changes
Other Study ID Numbers: BA3011-001
First Posted: February 7, 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
Pancreatic Neoplasms
Prostatic Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases