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

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ClinicalTrials.gov Identifier: NCT03425279
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
BioAtla, Inc.

Tracking Information
First Submitted Date  ICMJE January 22, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE February 15, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • 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
  • Dose Limiting Toxicities (DLTs) [ Time Frame: DLT will be assessed from first treatment cycle (3 weeks) ]
    Number of DLTs
  • Maximum Tolerated Dose (MTD) [ Time Frame: [Time Frame: MTD will be assessed from first treatment cycle (3 weeks)] ]
    Number of DLTs
  • Anti-tumor activity [ Time Frame: Up to 24 months ]
    Overall Response Rate (ORR) according to RECIST version 1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2018)
  • Pharmacokinetics: Cmax [ Time Frame: Up to 24 months ]
    Maximum observed concentration of BA3011
  • Pharmacokinetics: AUC [ Time Frame: Up to 24 months ]
    Area under the concentration versus time curve of BA3011
  • Immunogenicity of BA3011 [ Time Frame: Up to 24 months ]
    Presence of anti-drug antibodies (ADA)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Solid Tumors
Official Title  ICMJE A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 Alone and in Combination With Nivolumab in Adult and Adolescent Patients 12 Years and Older With Advanced Solid Tumors
Brief Summary The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors
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 in Phase 1 and BA3011 alone and in combination with nivolumab in Phase 2.

Phase 1 of this study will consist of a dose escalation phase (enrollment complete as of Oct 2019) and a dose expansion phase (still enrolling).

Phase 2 is targeted to begin in Q3 2020 and will include both adult and adolescents age 12 and over.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Pancreatic Cancer
  • Melanoma
  • Sarcoma
  • Sarcoma, Ewing
  • Osteosarcoma
  • Leiomyosarcoma
  • Synovial Sarcoma
  • Liposarcoma
  • Soft Tissue Sarcoma
  • Bone Sarcoma
  • Refractory Sarcoma
Intervention  ICMJE Biological: CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
Study Arms  ICMJE 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 nivolumab.
Intervention: Biological: CAB-AXL-ADC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2018)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have measurable disease.
  • Age ≥ 18 years (Phase 1); 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 received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration. (Phase 1 only)
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hazel Buncab, AD, ClinOps 858-263-1598 ext 8582631598 hbuncab@bioatla.com
Contact: Gerlee Thomas, Head of Regulatory 858-263-1598 gthomas@bioatla.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03425279
Other Study ID Numbers  ICMJE BA3011-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party BioAtla, Inc.
Study Sponsor  ICMJE BioAtla, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioAtla, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP