for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion
Principal Investigator
by Misako Nagasaka



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

Official Title

A Phase 1/2 Safety and Efficacy Dose Escalation / Dose Expansion Study of a CAB-ROR2-ADC, Alone and in Combination With a PD-1 Inhibitor, in Patients With Advanced Solid Tumors (Ph1) and Melanoma and NSCLC Patients (Ph2)


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) BA3021 in patients with advanced solid tumors.

This study will consist of a dose escalation phase and a dose expansion phase with BA3021 in Phase 1. Phase 2 will study BA3021 alone or in combination with a PD-1 inhibitor.


Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer, Head and Neck Neoplasms, Triple Negative Breast Neoplasms, Immune Checkpoint Inhibitors, CAB-ROR2-ADC, PD-1 inhibitor, Monotherapy - CAB-ROR2-ADC (BA3021) alone


You can join if…

Open to people ages 18 years and up

  • 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.

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 a history of ≥ Grade 3 allergic reactions to mAb therapy as wellas 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 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 known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
  • Patients must not be women who are pregnant or breast feeding.


  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • American Institute of Research completed
    Whittier California 90603 United States

Lead Scientist at UC Irvine

  • Misako Nagasaka
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 131 research publications


accepting new patients
Start Date
Completion Date
BioAtla, Inc.
Phase 1/2 research study
Study Type
Expecting 420 study participants
Last Updated