CAB-AXL-ADC Safety and Efficacy Study in Adults With NSCLC

Sponsor: BioAtla, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04681131

Patient View

This Phase 2, multi-center, open-label study evaluates the safety, tolerability, PK, immunogenicity, and antitumor activity of CAB-AXL-ADC, alone and with a PD-1 inhibitor, in adults with metastatic NSCLC. Eligible patients must have measurable disease, adequate organ function, and no significant cardiac issues. Exclusions include uncontrolled CNS metastasis and recent major surgery.

Patient Parameters

Program Overview

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

Description

This is a multi-center, open-label, Phase 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), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion Criteria

  • Patients must have measurable disease.
  • 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 had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
  • Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as 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
  • 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.

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