Non-Small-Cell Lung Cancer
Conditions
Keywords
Cancer
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).
Interventions
BIOLOGICALCAB-AXL-ADC
Conditionally active biologic anti-AXL antibody drug conjugate
BIOLOGICALPD-1 inhibitor
PD-1 inhibitor
Sponsors
BioAtla, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Overall survival (OS) | Up to 24 months | Time from the first dose of BA3021 treatment until death due to any cause. |
| Percent change from baseline in target lesion sum of diameters | Up to 24 months | — |
| Time to response (TTR) | Up to 24 months | Time from the first dose of investigational product until the first documentation of OR. |
| 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. |
Countries
Greece, Hong Kong, Italy, Poland, Spain, Taiwan, United States
Outcome results
None listed