This study is in progress, not accepting new patients

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 San Francisco, California and other locations
Dates
study started
completion around

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

  • UCSF
    San Francisco California 94158 United States
  • California Research Institute
    Los Angeles California 90027 United States

Details

Status
in progress, not 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