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

Phase 1

Active, not recruiting

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

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

Registration Number: NCT03504488

Lead Sponsor: BioAtla, Inc.

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

Detailed Description: 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.

Recruitment & Eligibility

Status: ACTIVE_NOT_RECRUITING

Sex: All

Target Recruitment: 420

Inclusion Criteria

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.

Exclusion Criteria

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.

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy - CAB-ROR2-ADC (BA3021) alone	CAB-ROR2-ADC	BA3021 alone Q2W dosing regimen
Combination Therapy	PD-1 inhibitor	CAB-ROR2-ADC (BA3021) with PD-1 inhibitor
Combination Therapy	CAB-ROR2-ADC	CAB-ROR2-ADC (BA3021) with PD-1 inhibitor

Primary Outcome Measures

Name	Time	Method
Phase 1: Safety Profile	Up to 24 months	Assess maximum tolerated dose as defined in the protocol
Phase 1 and 2: Safety Profile	Up to 24 months	Frequency and severity of AEs and/or SAEs
Phase 2: Confirmed Objective Response Rate (ORR)	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR

Secondary Outcome Measures

Name	Time	Method
Phase 1 and 2: Overall survival (OS)	Up to 24 months	Time from the first dose of BA3021 treatment until death due to any cause
Phase 1 and 2: Progression-free survival (PFS)	Up to 24 months	Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first
Phase 1: Pharmacokinetics	Up to 24 months	Area under the plasma concentration versus time curve
Phase 1: Confirmed Objective Response Rate (ORR)	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR
Phase 1 and 2: Tumor size	Up to 24 months	Percent change from baseline in tumor size
Phase 1 and 2: Duration of response (DOR)	Up to 24 months	Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first
Phase 1 and 2: Best overall response (OR)	Up to 24 months	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Phase 1 and 2: Disease control rate (DCR)	Up to 24 months	Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks
Phase 1: Immunogenicity	Up to 24 months	The number and percentage of patients who develop detectable anti-drug antibodies (ADAs)
Phase 1 and 2: Time to response (TTR)	Up to 24 months	Time from the first dose of investigational product until the first documentation of OR

Trial Locations

Locations (58): University of Arizona Cancer Center
🇺🇸
Tucson, Arizona, United States
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
American Institute of Research
🇺🇸
Whittier, 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
University of Colorado
🇺🇸
Aurora, Colorado, United States
Sarah Cannon Research Institute at Health One
🇺🇸
Denver, Colorado, United States
Florida Cancer Specialists & Research Institute
🇺🇸
Fort Myers, Florida, United States
Memorial Cancer Institute (MCI)
🇺🇸
Hollywood, Florida, United States
Florida Cancer Specialist - North
🇺🇸
Saint 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
NYU Langone Health
🇺🇸
New York, New York, United States
Roswell Park
🇺🇸
Buffalo, New York, United States
Columbia University Medical Center
🇺🇸
New York, New York, United States
FirstHealth Outpatient Cancer Center
🇺🇸
Pinehurst, North Carolina, United States
Wake Forest Baptist Health
🇺🇸
Winston-Salem, North Carolina, United States
The Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Oregon Health & Science University
🇺🇸
Portland, Oregon, United States
UPMC Cancer Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina- Hollings Cancer Center
🇺🇸
Charleston, South Carolina, United States
Sarah Cannon Research Institute
🇺🇸
Nashville, Tennessee, United States
Mary Crowley Cancer Research
🇺🇸
Dallas, Texas, United States
MD Anderson Cancer Center
🇺🇸
Houston, Texas, United States
University of Utah - Huntsman Cancer Institute
🇺🇸
Salt Lake City, Utah, United States
HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
🇬🇷
Athens, Greece
Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
🇬🇷
Piraeus, Greece
Bioclinic Thessaloniki, Οncology Department
🇬🇷
Thessaloniki, Greece
European Interbalkan Medical Center, Οncology Department
🇬🇷
Thessaloniki, Greece
Prince of Wales Hospital
🇭🇰
Hong Kong, Hong Kong
Queen Mary Hospital
🇭🇰
Hong Kong, Hong Kong
Polish Mother's Memorial Hospital-Research Institute
🇵🇱
Lodz, Lodzkie, Poland
Beata Głogowska
🇵🇱
Tomaszów Mazowiecki, Lodzkie, Poland
Institute of Genetics and Immunology GENIM LCC in Lublin
🇵🇱
Lublin, Lubelskie, Poland
Malgorzata Kozlik
🇵🇱
Warsaw, Mazowieckie, Poland
MED-Polonia, Sp. z o.o. (LLC)
🇵🇱
Poznan, Wielkopolskie, Poland
University Hospital Nuestra Senora de Valme
🇪🇸
Sevilla, Andalusia, Spain
University Clinic of Navarra - Madrid
🇪🇸
Madrid, Spain
University Hospital 12 de Octubre
🇪🇸
Madrid, Spain
Kaohsiung Chang Gung Memorial Hospital
🇨🇳
Kaohsiung City, Taiwan
National Cheng Kung University Hospital
🇨🇳
Tainan, Taiwan
National Taiwan University Hospital
🇨🇳
Taipei City, Taiwan
Hospital de la Santa Creu i Sant Pau
🇪🇸
Barcelona, Catalonia, Spain
Hospital del Mar
🇪🇸
Barcelona, Catalonia, Spain
Anna Ramos Luna
🇪🇸
Barcelona, Catalonia, Spain
LinKou Chang Gung Memorial Hospital
🇨🇳
Taoyuan City, Taiwan

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

Recruitment & Eligibility

Study & Design

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