The objective of this study is to assess safety and efficacy of CAB-AXL-ADC in NSCLC
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
85
Conditionally active biologic anti-AXL antibody drug conjugate
PD-1 inhibitor
Confirmed Objective Response Rate (ORR) per RECIST v1.1
Proportion of patients who achieve a confirmed CR or PR according to RECIST v1.1
Time frame: Up to 24 months
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
Time frame: Up to 24 months
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
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
Best overall response (BOR)
All post-baseline disease assessments that occur prior to the initiation of subsequent anticancer therapy
Time frame: Up to 24 months
Disease control rate (DCR)
Proportion of patients with a best overall response of confirmed CR, confirmed PR, or stable disease (SD) ≥ 12 weeks.
Time frame: Up to 24 months
Time to response (TTR)
Time from the first dose of investigational product until the first documentation of OR.
Time frame: Up to 24 months
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Duarte, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
Cedars-Sinai
Los Angeles, California, United States
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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
Fleming Island, Florida, United States
Florida Cancer Specialists & Research Institute
Fort Myers, Florida, United States
...and 50 more locations
Overall survival (OS)
Time from the first dose of BA3021 treatment until death due to any cause.
Time frame: Up to 24 months
Percent change from baseline in target lesion sum of diameters
Time frame: Up to 24 months