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

NCT03504488 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: BA3021-001
• Study Type: interventional
• Target: 132
• Locations: 6 countries
• Sites: 59

Brief Summary

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

Conditions

Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Melanoma; Head and Neck Cancer

Outcome Measures

Primary Outcomes (4)

• Phase 1: Safety Profile

  Assess dose limiting toxicity as defined in the protocol

  Up to 24 months

• Phase 1: Safety Profile

  Assess maximum tolerated dose as defined in the protocol

  Up to 24 months

• Phase 1 and 2: Safety Profile

  Frequency and severity of AEs and/or SAEs

  Up to 24 months

• Phase 2: Confirmed Objective Response Rate (ORR)

  Proportion of patients who achieve a confirmed CR or PR

  Up to 24 months

Secondary Outcomes (12)

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Pharmacokinetics

  Up to 24 months

• Phase 1: Confirmed Objective Response Rate (ORR)

  Up to 24 months

• Phase 1: Immunogenicity

  Up to 24 months

Study Arms (2)

Monotherapy - CAB-ROR2-ADC (BA3021) alone

EXPERIMENTAL

BA3021 alone Q2W dosing regimen

Biological: CAB-ROR2-ADC

Combination Therapy

EXPERIMENTAL

CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Biological: CAB-ROR2-ADC; Biological: PD-1 inhibitor

Interventions

CAB-ROR2-ADC BIOLOGICAL

Conditionally active biologic anti-ROR2 antibody drug conjugate

Also known as: BA3021

Combination Therapy; Monotherapy - CAB-ROR2-ADC (BA3021) alone

PD-1 inhibitor BIOLOGICAL

PD-1 inhibitor

Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• BioAtla, Inc.: lead

Study Sites (59)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

City of Hope - Duarte

Duarte, California, 91010, United States

Location

University of California, San Diego (UCSD) - Moores Cancer Center

La Jolla, California, 92093, United States

Location

California Research Institute

Los Angeles, California, 90027, United States

Location

USC Norris

Los Angeles, California, 90033, United States

Location

UC Irvine Medical Center - Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

American Institute of Research

Whittier, California, 90603, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Sarah Cannon Research Institute at Health One

Denver, Colorado, 80218, United States

Location

Florida Cancer Specialists & Research Institute

Fleming Island, Florida, 32003, United States

Location

Florida Cancer Specialists & Research Institute

Fort Myers, Florida, 33916, United States

Location

Memorial Cancer Institute (MCI)

Hollywood, Florida, 33028, United States

Location

Florida Cancer Specialist - North

St. Petersburg, Florida, 34474, United States

Location

Memorial Sloan-Kettering Cancer Center

Tampa, Florida, 33612, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Florida Cancer Specialists

West Palm Beach, Florida, 33401, United States

Location

Augusta University - Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Baptist Health Systems

Lexington, Kentucky, 40503, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Cancer Institute, Brownsboro Hospital Campus

Louisville, Kentucky, 40241, United States

Location

Hematology/Oncology Clinic

Baton Rouge, Louisiana, 70809, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Comprehensive Cancer Care of Nevada

Las Vegas, Nevada, 89169, United States

Location

OptumCare Cancer Care

Las Vegas, Nevada, 89169, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

UPMC Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Medical University of South Carolina- Hollings Cancer Center

Charleston, South Carolina, 29407, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Utah - Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit

Athens, 11526, Greece

Location

Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department

Piraeus, 18547, Greece

Location

Bioclinic Thessaloniki, Οncology Department

Thessaloniki, 54622, Greece

Location

European Interbalkan Medical Center, Οncology Department

Thessaloniki, 57001, Greece

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

MED-Polonia, Sp. z o.o. (LLC)

Poznan, Greater Poland Voivodeship, 60-693, Poland

Location

Institute of Genetics and Immunology GENIM LCC in Lublin

Lublin, Lublin Voivodeship, 20-609, Poland

Location

Malgorzata Kozlik

Warsaw, Masovian Voivodeship, 08-781, Poland

Location

Polish Mother's Memorial Hospital-Research Institute

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Beata Głogowska

Tomaszów Mazowiecki, Łódź Voivodeship, 97-200, Poland

Location

University Hospital Nuestra Senora de Valme

Seville, Andalusia, 41014, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08041, Spain

Location

Hospital del Mar

Barcelona, Catalonia, 089003, Spain

Location

Anna Ramos Luna

Barcelona, Catalonia, 08908, Spain

Location

University Clinic of Navarra - Madrid

Madrid, 28027, Spain

Location

University Hospital 12 de Octubre

Madrid, 28041, Spain

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

LinKou Chang Gung Memorial Hospital

Taoyuan, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Melanoma; Head and Neck Neoplasms

Interventions

Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: June 27, 2018
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

ES (6); TW (4); GR (4); PL (5); HK (2); US (38)