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Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma

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: NCT03425279
Recruitment Status : Recruiting
First Posted : February 7, 2018
Last Update Posted : September 13, 2021
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 September 13, 2021
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: September 7, 2021)
  • Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess dose limiting toxicity as defined in the protocol
  • Phase 1: Safety Profile [ Time Frame: Up to 24 months ]
    Assess maximum tolerated dose as defined in the protocol
  • Phase 1 and 2: Safety Profile [ Time Frame: Up to 24 months ]
    Frequency and severity of AEs and/or SAEs
  • 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
Original 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Plasma concentrations of ADC, total antibody and MMAE
  • Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Peak Plasma Concentration (Cmax)
  • Phase 1: Pharmacokinetics [ Time Frame: Up to 24 months ]
    Area under the plasma concentration versus time curve (AUC)
  • Phase 1: Overall response rate (ORR) [ Time Frame: Up to 24 months ]
    Proportion of patients who achieve a confirmed CR or PR
  • Phase 1: Immunogenicity [ Time Frame: Up to 24 months ]
    The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Phase 1 and 2: Tumor size [ Time Frame: Up to 24 months ]
    Percent change from baseline in tumor size
Original 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
Official Title  ICMJE A Phase 1/ 2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-AXL-ADC, Alone and in Combination With a PD-1 Inhibitor in Adult Patients With Advanced Solid Tumors (Phase 1) and Adult and Adolescent Patients With Advanced, Refractory Sarcoma (Phase 2)
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 a PD-1 inhibitor 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumor
  • Non Small Cell Lung 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
  • Biological: PD-1 inhibitor
    PD-1 inhibitor
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 PD-1 inhibitor.
    Intervention: Biological: CAB-AXL-ADC
  • Experimental: Combination Therapy
    Phase 2: BA3011 in combination with PD-1 inhibitor.
    Interventions:
    • Biological: CAB-AXL-ADC
    • Biological: PD-1 inhibitor
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 ≥ 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 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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hazel Buncab 858-263-1598 ext 8582631598 hbuncab@bioatla.com
Contact: Ji Hwan Lee 8582867702 jlee@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
Current Responsible Party BioAtla, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BioAtla, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BioAtla, Inc.
Verification Date January 2021

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