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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT04681131

Studienbeginn:
März 2021

Letztes Update:
06.08.2024

Wirkstoff:
CAB-AXL-ADC, PD-1 Inhibitor

Indikation (Clinical Trials):
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
BioAtla, Inc.

Collaborator:
-

Kontakt

BioAtla Medical Affairs
Kontakt:
Phone: 858-558-0708
Phone (ext.): 3333
E-Mail: medicalaffairs@bioatla.com» Kontaktdaten anzeigen

Studienlocations
(3 von 65)

Berlin Protestant Lung Hospital
13125 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
German Red Cross Clinics Berlin-Mitte
13359 Berlin
(Berlin)
GermanyZurückgezogen» Google-Maps
Clinics Essen-Mitte
45136 Essen
(Nordrhein-Westfalen)
GermanyZurückgezogen» Google-Maps
Asklepios Clinical Center Harburg
21075 Hamburg
(Hamburg)
GermanyZurückgezogen» Google-Maps
University of California Irvine Medical Center (UCIMC) - Chao Family Comprehensive Cancer Center
92868 Irvine
United StatesAktiv, nicht rekrutierend» Google-Maps
California Research Institute
90027 Los Angeles
United StatesAbgeschlossen» Google-Maps
University of California, San Diego (UCSD) - Moores Cancer Center
92093 San Diego
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Colorado Anschutz Medical Campus
80045 Aurora
United StatesAktiv, nicht rekrutierend» Google-Maps
Florida Cancer Specialists & Research Institute
32003 Fleming Island
United StatesAbgeschlossen» Google-Maps
Augusta University - Georgia Cancer Center
30912 Augusta
United StatesAbgeschlossen» Google-Maps
Baptist Health Systems
40503 Lexington
United StatesAbgeschlossen» Google-Maps
University of Kentucky
40536 Lexington
United StatesAbgeschlossen» Google-Maps
Norton Cancer Institute, Brownsboro Hospital Campus
40241 Louisville
United StatesAktiv, nicht rekrutierend» Google-Maps
University of Michigan Comprehensive Cancer Center
48202 Detroit
United StatesAktiv, nicht rekrutierend» Google-Maps
Comprehensive Cancer Centers of Nevada
89014 Henderson
United StatesAktiv, nicht rekrutierend» Google-Maps
OptumCare Cancer Care
89169 Las Vegas
United StatesAbgeschlossen» Google-Maps
NYU Langone Health
10016 New York
United StatesAktiv, nicht rekrutierend» Google-Maps
FirstHealth Outpatient Cancer Center
28374 Pinehurst
United StatesAktiv, nicht rekrutierend» Google-Maps
Gabrail Cancer Research Center
44718 Canton
United StatesAbgeschlossen» Google-Maps
The Lindner Research Center at the Christ Hospital
45219 Cincinnati
United StatesAbgeschlossen» Google-Maps
UPMC Cancer Center
15232 Pittsburgh
United StatesAktiv, nicht rekrutierend» Google-Maps
Sarah Cannon Research Institute
37203 Nashville
United StatesAbgeschlossen» Google-Maps
Mary Crowley Cancer Research
75230 Dallas
United StatesAbgeschlossen» Google-Maps
Henry Dunant Hospital Center
115 26 Athens
GreeceAbgeschlossen» Google-Maps
Sotiria Chest Diseases Hospital of Athens
11527 Athens
GreeceZurückgezogen» Google-Maps
Metropolitan Hospital Perseus Healthcare Group SA
185 47 Piraeus
GreeceAbgeschlossen» Google-Maps
Bioclinic Thessaloniki
546 22 Thessaloniki
GreeceAbgeschlossen» Google-Maps
Hospital San Giuseppe Moscati
83100 Avellino
ItalyAbgeschlossen» Google-Maps
European Institute of Oncology (IEO), IRCCS
20141 Milan
ItalyAbgeschlossen» Google-Maps
Santa Maria delle Croci Hospital of Ravenna
48121 Ravenna
ItalyAktiv, nicht rekrutierend» Google-Maps
Integrated University Hospital of Verona
37126 Verona
ItalyAbgeschlossen» Google-Maps
Specialistic Oncologic Hospital NU-MED
97-200 Tomaszów Mazowiecki
PolandAbgeschlossen» Google-Maps
Polish Mother's Memorial Hospital-Research Institute
93-338 Łódź
PolandAbgeschlossen» Google-Maps
Institute of Genetics and Immunology GENIM
20-609 Lublin
PolandAbgeschlossen» Google-Maps
MED-Polonia, Sp. z o.o. (LLC)
60-693 Poznań
PolandAktiv, nicht rekrutierend» Google-Maps
Hospital Universitario Virgen de Valme
41014 Sevilla
SpainAktiv, nicht rekrutierend» Google-Maps
Hospital de la Santa Creu i Sant Pau
08041 Barcelona
SpainAbgeschlossen» Google-Maps
Clinica Universidad de Navarra
31008 Pamplona
SpainAbgeschlossen» Google-Maps
Kaoshiung Chang Gung Memorial Hospital
Kaohsiung
TaiwanAbgeschlossen» Google-Maps
Taichung Veterans General Hospital
Taichung
TaiwanAbgeschlossen» Google-Maps
National Cheng Kung University Hospital
Tainan
TaiwanAbgeschlossen» Google-Maps
Alle anzeigen

Studien-Informationen

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).

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Confirmed Objective Response Rate (ORR) per RECIST v1.1 (Time Frame - Up to 24 months):
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1

2. Incidence of Adverse Events (AEs)or Serious Adverse Events (SAEs) as assessed by CTCAE v4.03/v5 (Time Frame - Up to 24 months):
Measured by frequency and severity of adverse events as assessed by CTCAE v4.03/v5

Secondary outcome:

1. Duration of response (DOR) (Time Frame - 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

2. Progression-free survival (PFS) (Time Frame - 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.

3. Best overall response (BOR) (Time Frame - Up to 24 months):
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy

4. Disease control rate (DCR) (Time Frame - Up to 24 months):
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.

5. Time to response (TTR) (Time Frame - Up to 24 months):
Time from the first dose of investigational product until the first documentation of OR.

6. Overall survival (OS) (Time Frame - Up to 24 months):
Time from the first dose of BA3021 treatment until death due to any cause.

7. Percent change from baseline in target lesion sum of diameters (Time Frame - Up to 24 months)

Studien-Arme

  • Experimental: CAB-AXL-ADC (BA3011)
    CAB-AXL-ADC (BA3011) alone
  • Experimental: CAB-AXL-ADC (BA3011)+PD-1 inhibitor
    CAB-AXL-ADC (BA3011) with PD-1 inhibitor

Geprüfte Regime

  • CAB-AXL-ADC (BA3011):
    Conditionally active biologic anti-AXL antibody drug conjugate
  • PD-1 inhibitor:
    PD-1 inhibitor

Quelle: ClinicalTrials.gov


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