Clinical Trials /

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

NCT03425279

Description:

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in solid tumors

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Solid Tumors
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: BA3011-001
  • NCT ID: NCT03425279

Conditions

  • 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

Interventions

DrugSynonymsArms
CAB-AXL-ADCBA3011

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
BA3011ExperimentalPhase 1: All patients will receive BA3011, CAB-AXL-ADC. Phase 2: All patients will receive either BA3011 alone or in combination with nivolumab.
  • CAB-AXL-ADC

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Frequency and severity of Treatment-Emergent Adverse Events (Safety and Tolerability of BA3011)
Time Frame:Up to 24 months
Safety Issue:
Description:Measured by frequency and severity of adverse events

Secondary Outcome Measures

Measure:Pharmacokinetics: Cmax
Time Frame:Up to 24 months
Safety Issue:
Description:Maximum observed concentration of BA3011
Measure:Pharmacokinetics: AUC
Time Frame:Up to 24 months
Safety Issue:
Description:Area under the concentration versus time curve of BA3011
Measure:Immunogenicity of BA3011
Time Frame:Up to 24 months
Safety Issue:
Description:Presence of anti-drug antibodies (ADA)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:BioAtla, LLC

Trial Keywords

  • late stage
  • stage 3
  • stage 4
  • cancer

Last Updated

June 12, 2020