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

a study on Lung Cancer Non-Small Cell Lung Cancer Lung Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD
Dates
study started
completion around
Principal Investigator
by Nagasaka Misako (uci)Lyudmila Bazhenova (ucsd)
Headshot of Lyudmila Bazhenova
Lyudmila Bazhenova

Description

Summary

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

Official Title

A Phase 2 Study of BA3011 Alone and in Combination With PD-1 Inhibitor in Adult Patients With Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor.

Details

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).

Keywords

Non-Small-Cell Lung Cancer, Cancer, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Immune Checkpoint Inhibitors, CAB-AXL-ADC, PD-1 inhibitor, CAB-AXL-ADC (BA3011), CAB-AXL-ADC (BA3011)+PD-1 inhibitor

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center accepting new patients
    Irvine California 92868 United States
  • University of California, San Diego (UCSD) - Moores Cancer Center accepting new patients
    San Diego California 92093 United States
  • Cedars-Sinai accepting new patients
    Los Angeles California 90048 United States
  • California Research Institute in progress, not accepting new patients
    Los Angeles California 90027 United States
  • USC Norris accepting new patients
    Los Angeles California 90033 United States
  • American Institute of Research accepting new patients
    Whittier California 90603 United States
  • City of Hope - Duarte in progress, not accepting new patients
    Duarte California 91010 United States

Lead Scientists at University of California Health

  • Nagasaka Misako (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 151 research publications
  • Lyudmila Bazhenova (ucsd)
    Dr. Bazhenova’s clinical practice and research concentrate on lung cancer, particularly as this relates to females and non-smokers. She actively participates in cooperative group trials, and takes an active role in designing and implementing clinical investigations, including phase II studies and correlative science projects with several UCSD investigators.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioAtla, Inc.
ID
NCT04681131
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated