Clinical Trials /

CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors

NCT03504488

Description:

The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
  • Non-Small Cell Lung Carcinoma
  • Soft Tissue Sarcoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: CAB-ROR2-ADC Safety and Efficacy Study in Patients With Solid Tumors
  • Official Title: A Phase 1/2 Dose Escalation and Dose Expansion Study of BA3021 in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: BA3021-001
  • NCT ID: NCT03504488

Conditions

  • Solid Tumor
  • Non Small Cell Lung Cancer
  • Triple Negative Breast Cancer
  • Soft Tissue Sarcoma

Interventions

DrugSynonymsArms
CAB-ROR2-ADCBA3021BA3021

Purpose

The objective of this study is to assess safety and efficacy of CAB-ROR2-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 BA3021, a conditionally active
      biologic (CAB) ROR2-targeted antibody drug conjugate (CAB-ROR2- ADC) in patients with
      advanced solid tumors. This study will consist of a dose escalation phase and a dose
      expansion phase.
    

Trial Arms

NameTypeDescriptionInterventions
BA3021ExperimentalAll patients will receive BA3021, CAB-ROR2-ADC.
  • CAB-ROR2-ADC

Eligibility Criteria

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed locally advanced
             unresectable or metastatic solid tumor and have failed all 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), triple negative breast cancer (TNBC)
             and soft tissue sarcoma (STS)

          -  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 BA3021
             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 BA3021)
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 BA3021
Measure:Pharmacokinetics; AUC
Time Frame:Up to 24 months
Safety Issue:
Description:Area under the concentration versus time curve of BA3021
Measure:Immunogenicity of BA3021
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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