CAB-AXL-ADC Safety and Efficacy Study in Adults with NSCLC

Phase 2

Active, not recruiting

• Conditions: Non-Small-Cell Lung Cancer
• Interventions: Biological: CAB-AXL-ADC; Biological: PD-1 inhibitor

• Registration Number: NCT04681131
• Lead Sponsor: BioAtla, Inc.

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).

Study Timeline

• Study First Submitted: 2020-12-08
• Study First Submitted QC: 2020-12-18
• Study First Posted: 2020-12-23
• Study Start: 2021-03-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 240

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CAB-AXL-ADC (BA3011)	CAB-AXL-ADC	CAB-AXL-ADC (BA3011) alone
CAB-AXL-ADC (BA3011)+PD-1 inhibitor	CAB-AXL-ADC	CAB-AXL-ADC (BA3011) with PD-1 inhibitor
CAB-AXL-ADC (BA3011)+PD-1 inhibitor	PD-1 inhibitor	CAB-AXL-ADC (BA3011) with PD-1 inhibitor

Primary Outcome Measures

Name	Time	Method
Confirmed Objective Response Rate (ORR) per RECIST v1.1	Up to 24 months	Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5	Up to 24 months	Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5

Secondary Outcome Measures

Name	Time	Method
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
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.
Best overall response (BOR)	Up to 24 months	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
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.
Time to response (TTR)	Up to 24 months	Time from the first dose of investigational product until the first documentation of OR.
Percent change from baseline in target lesion sum of diameters	Up to 24 months
Overall survival (OS)	Up to 24 months	Time from the first dose of BA3021 treatment until death due to any cause.

Trial Locations

Locations (59)

City of Hope - Duarte; 🇺🇸 Duarte, California, United States

University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center; 🇺🇸 Irvine, California, United States

California Research Institute; 🇺🇸 Los angeles, California, United States

USC Norris; 🇺🇸 Los angeles, California, United States

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

University of California, San Diego (UCSD) - Moores Cancer Center; 🇺🇸 San Diego, California, United States

American Institute of Research; 🇺🇸 Whittier, California, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Florida Cancer Specialists & Research Institute; 🇺🇸 Fort Myers, Florida, United States

Florida Cancer Specialist; 🇺🇸 Saint Petersburg, 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

University of Michigan Comprehensive Cancer Center; 🇺🇸 Detroit, Michigan, United States

Comprehensive Cancer Centers of Nevada; 🇺🇸 Henderson, Nevada, United States

OptumCare Cancer Care; 🇺🇸 Las Vegas, Nevada, United States

Roswell Park; 🇺🇸 Buffalo, New York, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

FirstHealth Outpatient Cancer Center; 🇺🇸 Pinehurst, North Carolina, United States

Gabrail Cancer Research Center; 🇺🇸 Canton, Ohio, United States

The Lindner Research Center at the Christ Hospital; 🇺🇸 Cincinnati, Ohio, 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; 🇺🇸 Houston, Texas, United States

Henry Dunant Hospital Center; 🇬🇷 Athens, Greece

Metropolitan Hospital Perseus Healthcare Group SA; 🇬🇷 Piraeus, Greece

Bioclinic Thessaloniki; 🇬🇷 Thessaloniki, Greece

European Interbalkan Medical Center; 🇬🇷 Thessaloniki, Greece

ICON Cancer Centre; 🇭🇰 Hong Kong, Hong Kong

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong

Hong Kong United Oncology Centre; 🇭🇰 Kowloon, Hong Kong

"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."; 🇮🇹 Genoa, Liguria, Italy

Hospital San Giuseppe Moscati; 🇮🇹 Avellino, Italy

European Institute of Oncology (IEO), IRCCS; 🇮🇹 Milan, Italy

Santa Maria delle Croci Hospital of Ravenna; 🇮🇹 Ravenna, Italy

Integrated University Hospital of Verona; 🇮🇹 Verona, Italy

Specialistic Oncologic Hospital NU-MED; 🇵🇱 Tomaszów Mazowiecki, Lodzkie, Poland

Polish Mother's Memorial Hospital-Research Institute; 🇵🇱 Łódź, Lodzkie, Poland

Institute of Genetics and Immunology GENIM; 🇵🇱 Lublin, Lubelskie, Poland

MED-Polonia, Sp. z o.o. (LLC); 🇵🇱 Poznań, Wielkopolskie, Poland

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Andalusia, Spain

Hospital del Mar; 🇪🇸 Barcelona, Catalonia, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Catalonia, Spain

Catalan Institute of Oncology, Hospital Duran i Reynals; 🇪🇸 Barcelona, Catalonia, Spain

Maria Sklodowska-Curie - National Research Institute of Oncology; 🇵🇱 Warsaw, Mazowieckie, Poland

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain

University Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Kaoshiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Taichung Veterans General Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan