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

Completed · Phase 1/Phase 2

Conditions studied: Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer

In brief

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

Key facts

Study ID

NCT03504488

Run by

BioAtla, Inc.

People needed

132

Starts

2018-06-27

Expected to finish

2024-12-30

Last updated by the study team

2025-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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.

Where it is running

• City of Hope - Duarte — Duarte, California, United States
• University of California, San Diego (UCSD) - Moores Cancer Center — La Jolla, California, United States
• California Research Institute — Los Angeles, California, United States
• USC Norris — Los Angeles, California, United States
• UC Irvine Medical Center - Chao Family Comprehensive Cancer Center — Orange, California, United States
• University of California San Francisco — San Francisco, California, United States
• American Institute of Research — Whittier, California, United States
• University of Colorado — Aurora, Colorado, United States
• Sarah Cannon Research Institute at Health One — Denver, Colorado, United States
• Florida Cancer Specialists & Research Institute — Fleming Island, Florida, United States
• Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States
• Memorial Cancer Institute (MCI) — Hollywood, Florida, United States
• Florida Cancer Specialist - North — St. Petersburg, Florida, United States
• Memorial Sloan-Kettering Cancer Center — Tampa, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Florida Cancer Specialists — West Palm Beach, Florida, United States
• Augusta University - Georgia Cancer Center — Augusta, Georgia, United States
• Baptist Health Systems — Lexington, Kentucky, United States
• University of Kentucky — Lexington, Kentucky, United States
• Norton Cancer Institute, Brownsboro Hospital Campus — Louisville, Kentucky, United States
• Hematology/Oncology Clinic — Baton Rouge, Louisiana, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Comprehensive Cancer Care of Nevada — Las Vegas, Nevada, United States
• OptumCare Cancer Care — Las Vegas, Nevada, United States
• University of Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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