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

Non-Small-Cell Lung Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681131
• Other study ID #: BA3011-002
• Status: Recruiting
• Phase: Phase 2
• Start date: March 17, 2021
• Est. completion date: August 2025

Study information

• Verified date: January 2024
• Source: BioAtla, Inc.
• Contact: BioAtla Medical Affairs
• Phone: 858-558-0708
• Email: medicalaffairs[@]bioatla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small-Cell Lung Cancer

Intervention

Biological:
• CAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
• PD-1 inhibitor
PD-1 inhibitor

Locations

Country	Name	City	State
Germany	Berlin Protestant Lung Hospital	Berlin
Germany	German Red Cross Clinics Berlin-Mitte	Berlin
Germany	Clinics Essen-Mitte	Essen
Germany	Asklepios Clinical Center Harburg	Hamburg
Greece	Henry Dunant Hospital Center	Athens
Greece	Sotiria Chest Diseases Hospital of Athens	Athens
Greece	Metropolitan Hospital Perseus Healthcare Group SA	Piraeus
Greece	Bioclinic Thessaloniki	Thessaloniki
Greece	European Interbalkan Medical Center	Thessaloniki
Hong Kong	ICON Cancer Centre	Hong Kong
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Hong Kong United Oncology Centre	Kowloon
Italy	Hospital San Giuseppe Moscati	Avellino
Italy	"IRCCS Osp. Policlinico San Martino Pad Ex microbiologia, stanza 9, 1 piano."	Genoa	Liguria
Italy	European Institute of Oncology (IEO), IRCCS	Milan
Italy	Santa Maria delle Croci Hospital of Ravenna	Ravenna
Italy	Integrated University Hospital of Verona	Verona
Poland	Polish Mother's Memorial Hospital-Research Institute	Lódz	Lodzkie
Poland	Institute of Genetics and Immunology GENIM	Lublin	Lubelskie
Poland	MED-Polonia, Sp. z o.o. (LLC)	Poznan	Wielkopolskie
Poland	Specialistic Oncologic Hospital NU-MED	Tomaszów Mazowiecki	Lodzkie
Poland	Maria Sklodowska-Curie - National Research Institute of Oncology	Warsaw	Mazowieckie
Spain	Catalan Institute of Oncology, Hospital Duran i Reynals	Barcelona	Catalonia
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalonia
Spain	Hospital del Mar	Barcelona	Catalonia
Spain	University Hospital 12 de Octubre	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario Virgen de Valme	Sevilla	Andalusia
Taiwan	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
United States	Augusta University - Georgia Cancer Center	Augusta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Hematology/Oncology Clinic	Baton Rouge	Louisiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park	Buffalo	New York
United States	Gabrail Cancer Research Center	Canton	Ohio
United States	Medical University of South Carolina- Hollings Cancer Center	Charleston	South Carolina
United States	The Lindner Research Center at the Christ Hospital	Cincinnati	Ohio
United States	Mary Crowley Cancer Research	Dallas	Texas
United States	University of Michigan Comprehensive Cancer Center	Detroit	Michigan
United States	City of Hope - Duarte	Duarte	California
United States	Florida Cancer Specialists & Research Institute	Fleming Island	Florida
United States	Florida Cancer Specialists & Research Institute	Fort Myers	Florida
United States	Comprehensive Cancer Centers of Nevada	Henderson	Nevada
United States	MD Anderson	Houston	Texas
United States	University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center	Irvine	California
United States	OptumCare Cancer Care	Las Vegas	Nevada
United States	Baptist Health Systems	Lexington	Kentucky
United States	University of Kentucky	Lexington	Kentucky
United States	California Research Institute	Los Angeles	California
United States	Cedars-Sinai	Los Angeles	California
United States	USC Norris	Los Angeles	California
United States	Norton Cancer Institute, Brownsboro Hospital Campus	Louisville	Kentucky
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	NYU Langone Health	New York	New York
United States	FirstHealth Outpatient Cancer Center	Pinehurst	North Carolina
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Florida Cancer Specialist	Saint Petersburg	Florida
United States	University of California, San Diego (UCSD) - Moores Cancer Center	San Diego	California
United States	Moffitt Cancer Center	Tampa	Florida
United States	Florida Cancer Specialists	West Palm Beach	Florida
United States	American Institute of Research	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
BioAtla, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Greece,  Hong Kong,  Italy,  Poland,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmed Objective Response Rate (ORR) per RECIST v1.1	Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1	Up to 24 months
Primary	Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5	Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5	Up to 24 months
Secondary	Duration of response (DOR)	Time from the first documented OR until the first documented disease progression or death (due to any cause), whichever occurs first	Up to 24 months
Secondary	Progression-free survival (PFS)	Time from the first dose of IP until the first documentation of disease progression or death due to any cause, whichever occurs first.	Up to 24 months
Secondary	Best overall response (BOR)	All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy	Up to 24 months
Secondary	Disease control rate (DCR)	Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) = 12 weeks.	Up to 24 months
Secondary	Time to response (TTR)	Time from the first dose of investigational product until the first documentation of OR.	Up to 24 months
Secondary	Overall survival (OS)	Time from the first dose of BA3021 treatment until death due to any cause.	Up to 24 months
Secondary	Percent change from baseline in target lesion sum of diameters		Up to 24 months