Clinical trial NCT03504488: CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non Small Cell Lung Cancer
Triple Negative Breast Cancer
Melanoma
Head and Neck Cancer
Lead sponsor: BioAtla, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Phase 1: Safety Profile
timeFrame: Up to 24 months
measure: Phase 1: Safety Profile
timeFrame: Up to 24 months
measure: Phase 1 and 2: Safety Profile
timeFrame: Up to 24 months
measure: Phase 2: Confirmed Objective Response Rate (ORR)
timeFrame: Up to 24 months
Secondary outcomes:
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Pharmacokinetics
timeFrame: Up to 24 months
measure: Phase 1: Confirmed Objective Response Rate (ORR)
timeFrame: Up to 24 months
measure: Phase 1: Immunogenicity
timeFrame: Up to 24 months
measure: Phase 1 and 2: Duration of response (DOR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Best overall response (OR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Time to response (TTR)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Overall survival (OS)
timeFrame: Up to 24 months
measure: Phase 1 and 2: Tumor size
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona Cancer Center
state: Arizona
city: Duarte
country: United States
facility: City of Hope - Duarte
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD) - Moores Cancer Center
state: California
city: Los Angeles
country: United States
facility: California Research Institute
state: California
city: Los Angeles
country: United States
facility: USC Norris
state: California
city: Orange
country: United States
facility: UC Irvine Medical Center - Chao Family Comprehensive Cancer Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Denver
country: United States
facility: Sarah Cannon Research Institute at Health One
state: Colorado
city: Fleming Island
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists & Research Institute
state: Florida
city: Hollywood
country: United States
facility: Memorial Cancer Institute (MCI)
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialist - North
state: Florida
city: Tampa
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Augusta
country: United States
facility: Augusta University - Georgia Cancer Center
state: Georgia
city: Lexington
country: United States
facility: Baptist Health Systems
state: Kentucky
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute, Brownsboro Hospital Campus
state: Kentucky
city: Baton Rouge
country: United States
facility: Hematology/Oncology Clinic
state: Louisiana
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Care of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care
state: Nevada
city: Buffalo
country: United States
facility: Roswell Park
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina- Hollings Cancer Center
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Athens
country: Greece
facility: HENRY DUNANT Hospital Center, 4th Department of Medical Oncology and Clinical Trials Unit
city: Piraeus
country: Greece
facility: Metropolitan Hospital "Perseus Healthcare Group SA" 4th Oncology Department
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki, Οncology Department
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center, Οncology Department
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Lodz
country: Poland
facility: Polish Mother's Memorial Hospital-Research Institute
state: Lodzkie
city: Tomaszów Mazowiecki
country: Poland
facility: Beata Głogowska
state: Lodzkie
city: Lublin
country: Poland
facility: Institute of Genetics and Immunology GENIM LCC in Lublin
state: Lubelskie
city: Warsaw
country: Poland
facility: Malgorzata Kozlik
state: Mazowieckie
city: Poznan
country: Poland
facility: MED-Polonia, Sp. z o.o. (LLC)
state: Wielkopolskie
city: Sevilla
country: Spain
facility: University Hospital Nuestra Senora de Valme
state: Andalusia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
city: Barcelona
country: Spain
facility: Anna Ramos Luna
state: Catalonia
city: Madrid
country: Spain
facility: University Clinic of Navarra - Madrid
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre
city: Kaohsiung City
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan City
country: Taiwan
facility: LinKou Chang Gung Memorial Hospital
Study officials:
References: