Clinical trial NCT04681131: CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC
Official title: A Phase 2 Study of BA3011 Alone and in Combination with PD-1 Inhibitor in Adult Patients with Metastatic Non-small Cell Lung Cancer (NSCLC) Who Had Prior Disease Progression on a PD-1/L-1 Inhibitor, EGFR, or ALK Inhibitor.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Non-Small-Cell Lung Cancer
Keywords: Cancer
Lead sponsor: BioAtla, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-23
Enrollment: 240
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-AXL-ADC in NSCLC

Detailed description: This is a multi-center, open-label, Phase 2 study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3011, a conditionally active biologic (CAB) AXL-targeted antibody drug conjugate (CAB-AXL-ADC), alone and in combination with PD-1 inhibitor in patients with metastatic non-small cell lung cancer (NSCLC).

Eligibility criteria: Inclusion Criteria:

* Patients must have measurable disease.
* 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 had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as 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 BA3011
* 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: Confirmed Objective Response Rate (ORR) per RECIST v1.1
timeFrame: Up to 24 months
measure: Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5
timeFrame: Up to 24 months
Secondary outcomes:
measure: Duration of response (DOR)
timeFrame: Up to 24 months
measure: Progression-free survival (PFS)
timeFrame: Up to 24 months
measure: Best overall response (BOR)
timeFrame: Up to 24 months
measure: Disease control rate (DCR)
timeFrame: Up to 24 months
measure: Time to response (TTR)
timeFrame: Up to 24 months
measure: Overall survival (OS)
timeFrame: Up to 24 months
measure: Percent change from baseline in target lesion sum of diameters
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope - Duarte
state: California
city: Irvine
country: United States
facility: University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive 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: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: San Diego
country: United States
facility: University of California, San Diego (UCSD) - Moores Cancer Center
state: California
city: Whittier
country: United States
facility: American Institute of Research
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
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: Saint Petersburg
country: United States
facility: Florida Cancer Specialist
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: Detroit
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Henderson
country: United States
facility: Comprehensive Cancer Centers 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: Pinehurst
country: United States
facility: FirstHealth Outpatient Cancer Center
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Research Center
state: Ohio
city: Cincinnati
country: United States
facility: The Lindner Research Center at the Christ Hospital
state: Ohio
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
state: Texas
city: Athens
country: Greece
facility: Henry Dunant Hospital Center
city: Piraeus
country: Greece
facility: Metropolitan Hospital Perseus Healthcare Group SA
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center
city: Hong Kong
country: Hong Kong
facility: ICON Cancer Centre
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Kowloon
country: Hong Kong
facility: Hong Kong United Oncology Centre
city: Genoa
country: Italy
facility: "IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."
state: Liguria
city: Avellino
country: Italy
facility: Hospital San Giuseppe Moscati
city: Milan
country: Italy
facility: European Institute of Oncology (IEO), IRCCS
city: Ravenna
country: Italy
facility: Santa Maria delle Croci Hospital of Ravenna
city: Verona
country: Italy
facility: Integrated University Hospital of Verona
city: Tomaszów Mazowiecki
country: Poland
facility: Specialistic Oncologic Hospital NU-MED
state: Lodzkie
city: Łódź
country: Poland
facility: Polish Mother's Memorial Hospital-Research Institute
state: Lodzkie
city: Lublin
country: Poland
facility: Institute of Genetics and Immunology GENIM
state: Lubelskie
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie - National Research Institute of Oncology
state: Mazowieckie
city: Poznań
country: Poland
facility: MED-Polonia, Sp. z o.o. (LLC)
state: Wielkopolskie
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
state: Andalusia
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Barcelona
country: Spain
facility: Catalan Institute of Oncology, Hospital Duran i Reynals
state: Catalonia
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
city: Madrid
country: Spain
facility: University Hospital 12 de Octubre
city: Kaohsiung
country: Taiwan
facility: Kaoshiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
References: