Clinical Trials /

CAB-AXL-ADC Safety and Efficacy Study in 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
  • Melanoma
  • Non-Small Cell Lung Carcinoma
  • Pancreatic Ductal Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CAB-AXL-ADC Safety and Efficacy Study in Patients With Solid Tumors
  • Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3011 in Patients 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

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.

      This study will consist of a dose escalation phase and a dose expansion phase.
    

Trial Arms

NameTypeDescriptionInterventions
BA3011ExperimentalAll patients will receive BA3011, CAB-AXL-ADC.
  • CAB-AXL-ADC

Eligibility 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), melanoma, 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.
      
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

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