CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)

a study on Lung Cancer Non-Small Cell Lung Cancer Breast Cancer Triple-Negative Breast Cancer Skin Cancer/Melanoma Head and Neck Cancer Solid Tumor Head and Neck Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSD UCSF
Dates
study start
estimated completion
Principal Investigator
by Lyudmila Bazhenova (ucsd)Misako Nagasaka (uci)Katy Tsai, MD (ucsf)
Headshot of Lyudmila Bazhenova
Lyudmila Bazhenova
Headshot of Katy Tsai
Katy Tsai

Description

Summary

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)

Details

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.

Keywords

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

Eligibility

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.

Locations

  • University of California, San Diego (UCSD) - Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • UC Irvine Medical Center - Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • California Research Institute accepting new patients
    Los Angeles California 90027 United States
  • USC Norris accepting new patients
    Los Angeles California 90033 United States
  • American Institute of Research completed
    Whittier California 90603 United States
  • City of Hope - Duarte accepting new patients
    Duarte California 91010 United States

Lead Scientists at University of California Health

  • 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.
  • Misako Nagasaka (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 139 research publications
  • Katy Tsai, MD (ucsf)
    Dr. Katy K. Tsai is a medical oncologist and clinical researcher who specializes in treating advanced melanoma and other non-melanoma skin cancers, such as squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma. Dr. Tsai graduated with a degree in comparative literature from Brown University before earning her medical degree from Brown.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BioAtla, Inc.
ID
NCT03504488
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 420 study participants
Last Updated