BA3011-002


A Phase 2 Study of BA3011 Alone and in Combination with Nivolumab in Adult Patients with Metastatic Non-Small Cell Lung Cancer Who Had Prior Disease Progression on a PD-1/L1, EGFR, or ALK Inhibitor

Trial summary:

BA3011-002 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). The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC.

Receptor status / problem studied:

PD-1/ L-1 inhibitor

Inclusion criteria

  • Age ≥ 18 years
  • Patients must have measurable disease:
    • Have histologically or cytologically confirmed locally advanced unresectable or metastatic NSCLC.
    • Have prior disease progression on or after receiving an approved PD-1/L1, EGFR or ALK inhibitor (either monotherapy or in combination with another therapy).
  • Patients must have:
    • Completed (and recovered from treatment-related toxicities) any prior treatment with radiotherapy, chemotherapy, and/or treatment with other investigational anticancer agents at least 5 half-lives, or 2 weeks, prior to first study dose, or biologics (such as a monoclonal antibody [mAb]) at least 4 weeks prior to first study dose. Exceptions are bisphosphonates, denosumab and gonadotropin-releasing hormone agonist or antagonist.
    • Completed any prior treatment with nitrogen mustard agents, melphalan, or carmustine (BCNU) therapy at least 6 weeks prior to first study dose.
    • Received any prior autologous hematopoietic stem cell infusion at least 8 weeks prior to first study dose.
  • 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.

View more trial information

Open for recruitment

Trial Title

BA3011-002

Diagnosis

Lung cancer

Type of trial

Pharmaceutical

Type of treatement

Medical Oncology

Phase

II

Investigators

Principal Investigator
View all clinical trials

Search

Contact us
Become a patient